CAM 20179

Non-contact Ultrasound Treatment of Wounds

Category:Medicine   Last Reviewed:October 2018
Department(s):Medical Affairs   Next Review:October 2019
Original Date:November 2008    

Description:
Low-frequency ultrasound in the kilohertz range may improve wound healing. Several noncontact low-frequency ultrasound (NLFU) devices have received regulatory approval for wound treatment.

For individuals who have any wound type (acute or nonhealing) who receive noncontact ultrasound therapy, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. The single double-blinded, sham-controlled randomized trial, which included patients with nonhealing diabetic foot ulcers, had substantial methodologic flaws (e.g., high dropout rate, baseline differences between groups) that limit the validity of the findings. In the remaining studies comprising the evidence base, all but 1 RCT comparing NLFU with standard wound care had improved (statistically significant) results on the primary outcome with NLFU. However, these studies also had several methodologic limitations. In terms of outcome assessment, complete healing is generally considered the most clinically relevant outcome; a 50% reduction in wound area over time and time to heal are also considered acceptable outcomes. A majority of trials included patients with venous leg ulcers. None of the RCTs evaluating venous leg ulcers reported complete healing or another acceptable outcome as its primary outcome measure, and none had blinded outcome assessment. Only 1 RCT, which addressed split-thickness graft donor sites, reported on the proportion of patients with complete healing and had blinded outcome assessment. Another limitation of the body of evidence is that some standard of care interventions involved fewer visits than the NLFU intervention, and the differences in intensity of care resulting from this differential in face-to-face contact could partially explain the difference in findings between intervention and control groups. The evidence is insufficient to determine the effects of the technology on health outcomes.

Background 
Ultrasound (US) delivers mechanical vibration above the upper threshold of human hearing (>20 kHz). US in the megahertz range (1-3 MHz) has been used to treat musculoskeletal disorders, often by physical therapists. Although the exact mechanism underlying its clinical effects is not known, therapeutic US has been shown to have a variety of effects at a cellular level, including angiogenesis, leukocyte adhesion, growth factor, collagen production, and increases in macrophage responsiveness, fibrinolysis, and nitric oxide levels. The therapeutic effects of US energy in the kilohertz range have also been examined. Although the precise effects are not known, the low-frequency US in this range may improve wound healing via the production, vibration, and movement of micron-sized bubbles in the coupling medium and tissue.

The mechanical energy from the US is typically transmitted to the tissue through a coupling gel. Several high-intensity US devices with contact probes are currently available for wound débridement. Low- intensity US devices have been developed that do not require coupling gel or other direct contact. The MIST Therapy System delivers a saline mist to the wound with low-frequency US (40 KHz). A second device, the Qoustic Wound Therapy System, also uses sterile saline to deliver US energy (35 KHz) for wound débridement and irrigation.

US is intended as an adjunct to standard wound care. Therefore, the evidence is needed that demonstrates US plus standard wound care provides superior wound closure outcomes compared with standard wound care alone.

The primary end points of interest for trials of wound closure are as follows, consistent with 2006 guidance from the U.S. Food and Drug Administration for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds1:

  1. Incidence of complete wound closure.
  2. Time to complete wound closure (reflecting accelerated wound closure).
  3. Incidence of complete wound closure following surgical wound closure.
  4. Pain control.

Regulatory Status
In 2005, the MIST Therapy® device (Celleration) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process "to promote wound healing through wound cleansing and maintenance débridement by the removal of yellow slough, fibrin, tissue exudates and bacteria."
2 In February 2015, Celleration was acquired by Alliqua Biomedical (Langhorne, PA).

In 2007, the AR1000 Ultrasonic Wound Therapy System (Arobella Medical, Minnetonka, MN) was cleared for marketing by FDA through the 510(k) process, listing the MIST Therapy® system and several other ultrasonic wound débridement and hydrosurgery systems as predicate devices. The AR1000 system probe uses "contact or noncontact techniques to achieve intended wound therapy modalities to promote wound healing."3 Indications in the 510(k) summary are listed as "Selective and non-selective dissection and fragmentation of soft and or hard tissue" and "Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, bums) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates, bacteria and other matter."3 This device is now known as the Qoustic Wound Therapy System™.

Several other devices have been approved as being substantially equivalent to the earlier devices. FDA product code: NRB.

Related Policies
10116 Negative Pressure Wound Therapy
20157 Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds

Policy:
Non-contact ultrasound treatment for wounds is considered INVESTIGATIONAL. 

Policy Guidelines
There is a category I CPT code specific to this treatment:

97610: Low frequency, non-contact, nonthermal ultrasound, including topical application(s), when performed, wound assessment and instruction(s) for ongoing care, per day.

Benefit Application
BlueCard®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational, and, thus, these devices may be assessed only on the basis of their medical necessity.

Rationale
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function—including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical uses of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

This literature review focuses on evidence evaluating whether the addition of noncontact low-frequency ultrasound (NLFU) improves wound healing compared with standard treatment alone. Observational studies may be considered if they provide additional information on adverse events or durability. 

NONCONTACT LOW-FREQUENCY ULTRASOUND 
Systematic Reviews
In 2015, Tricco et al published an overview of systematic reviews on treatments for complex wounds, which reviewed multiple therapies including ultrasound.4 The 2011 review by Voigt et al was included. Conclusions related to ultrasound therapy are summarized in Table 1. 

Table 1. Overview and Summary Conclusions of Systematic Reviews 

Disorder

Intervention

Outcome

Type of Review Available

Level of Evidence

Conclusion

Venous ulcer

US

Time to healing/rate of healing

SR w/o MA

Low/moderate

No difference

Venous ulcer

HFUS, LFUS, US

Proportion of patients with healed wounds

SR with MA

High

No difference

Mixed arterial/ venous ulcer

US

Wound area/size reduction

SR with MA

Low/moderate

Effective

Diabetic ulcer

US

Ulcer healing

SR w/o MA

Low/moderate

No difference

Pressure ulcer

US

Wound area/size reduction, time to healing/rate of healing

SR w/o MA

Low/moderate

No difference

Pressure ulcer

US

Proportion of patients with healed wounds

SR with MA

High and low/moderate

No difference

Pressure ulcer

US

Proportion of patients with healed wounds

SR w/o MA

Low/moderate

Uncertain (conflicting evidence or indeterminate)

Adapted from Trico et al (2015).4
HFUS: high-frequency ultrasound; LFUS: low-frequency ultrasound; MA: meta-analysis; QOE: quality of evidence; SR: systematic review; US: ultrasound; w/o: without.

Tables 2 and 3 summarize systematic reviews that compare results from NLFU with standard care. The Voigt et al (2011) systematic review only included RCTs; studies used contact or noncontact ultrasound for treating chronic lower-limb wounds.5 Five RCTs on NLFU were identified, one of which was unpublished. A pooled analysis of 2 sham-controlled trials found a significantly smaller proportion of nonhealed wounds at 3 months in the NLFU group than in the control group (relative risk, 0.74; 95% confidence interval, 0.58 to 0.95; p=0.02). The 2 NLFU studies were those by Ennis et al (2005; described in the following section),6 and by Peschen et al (1997),7 which delivered ultrasound therapy with a dated device during foot bathing. A 2017 systematic review by Chang et al8 included all study types; however, only 2 of the RCTs (Ennis et al [2005]6 and Kavros et al [2007]9) were included. Chang (2017) did not include meta-analyses, and the narrative synthesis did not provide complete information on the range of comparative effects; therefore, it is not included in the tables below.

Table 2. Systematic Review Characteristics

Study (Year)

Dates

Studies

Participants

N (Range)

Design

Duration, mo

Voight et al (2011)5

Up to Mar 2011

2

Patients with chronic lower-limb wounds

22-55

RCTs

2-3

RCT: randomized controlled trial. 

Table 3. Systematic Review Results

Study (Year)

Time to Complete Wound Healing

% Nonhealed Wounds at 3 mo

Pain Outcomes

Safety Outcomes

Voight et al (2011)5

Total N

NR

77

NR

NR

Pooled effect (95% CI)

 

RR=0.74 (0.58 to 0.95), p=0.02

 

 

I2, %

 

0

 

 

CI: confidence interval; NR: not reported; RR, relative risk.

Randomized Controlled Trials
One double-blind, multicenter, sham-controlled trial and a number of unblinded RCTs comparing NLFU with standard wound care alone have been performed. Trials including at least 25 patients are described in the Tables 4-7 and the following text. All RCTs used MIST therapy and, other than Beheshti et al (2014)10 and Olyaie et al (2013),11 which did not report funding sources, all were industry-funded. One study addressed diabetic foot ulcers. Four RCTs included patients with venous leg ulcers and another evaluated treatment of split-thickness graft donor sites. All studies except that on split-thickness graft donor sites included patients with nonhealing wounds; eligibility criteria included wounds that had not healed after at least 4 weeks. Standard care interventions varied, but generally consisted of wound cleaning, noncontact dressings, compression and, if deemed necessary by providers, débridement. In 2 studies (White et al [2016]12, Gibbons et al [2015]13), authors mentioned following national guidelines for the standard of care intervention. Prather et al (2015)14 did not describe the standard care intervention and Beheshti et al reported only that compression was used.

Table 4. Summary of RCT Characteristicsa

 

 

   

 

Interventions

Author (Year)

Countries

Sites Dates

Participants

Active

Comparator 

White et al (2016)12

UK 1

Aug 2012-Nov 2013

Patients with venous leg ulcers (≥6 wk)
  • n=17
  • NLFU: 3´/wk for 8 wk (after 2-wk run-in) + SOC
  • n=19
  • SOC: >1 visit per week for 8 wk

Gibbons et al (2015)13

      US

22

Apr 2012-Mar 2014

Patients with venous leg ulcers (≥30 d)
  • n=40
  • NLFU: 3´/wk for 4 wk + SOC 
  • n=41
  • SOC: 3 x/wk for 4 wk

Prather et al (2015)14 

      US

1

Feb 2012-Jul 2013

Patients with split- thickness graft donor sites
  • n=16
  • NLFU: 1´/wk for 5 consecutive days (after 2-wk
  • n=15
  • SOC: 3 x/wk for 5 consecutive days (after 2 wk run-in)

Olyaie et al (2013)11 

      Iran

1

Apr 2011-Apr 2012

Patients with venous leg ulcers (≥4 wk)
  • n=30
  • NLFU: 3´/wk for 3 mo or until healed + SOC
  • n=30 
  • HFU: 3´/wk for 3 mo or until healed + SOC
  • n=30
  • SOC: 1 x/wk for 3 mo or until healed

Beheshti et al (2014)10

Iran 1

Apr 2011-Apr 2012

Patients with venous leg ulcers (≥4 wk)
  • n=30
  • NLFU: 3´/wk until healed + SOC
  • n=30
  • HFU: 3´/wk until healed + SOC
  • n=30
  • SOC: Compression therapy (visit frequency NR)

Kavros et al(2007)9 

US 1 2004-2006 Patients with nonhealing foot, ankle, or leg wounds (≥8wk) 
  • n=35
  • NLFU: 3´/wk for 12 wk +SOC   
  • n=35
  • SOC: daily visits

Ennis et al (2005)6 

US, Canada

 26

 NR

Patientswith diabetic footulcers 

  • n=70
  • NLFU: 3´/wk for 12 wk + SOC 
  • n=63
  • SOC: 3 x/wk for 12 wK

NLFU: noncontact low-frequency ultrasound; NR: not reported; RCT: randomized controlled trial; SOC: standard of care.
a Includes trials with ≥25 participants.

Table 5. Summary of RCT Resultsa

Study (Year)  

Time to Complete Wound Healing 

% With Complete Wound Healing

Change in Wound Size

Pain Outcomes

Adverse Events

 

 

At 8 Wk

Mean % Change in Wound Area at 8 Wk

Mean Reduction in VAS Pain Score at 8 Wk

 No. of Events

White et al (2016)12

 

 

 

 

 

N                              

NR 

36

36

36

36

NLFU+SOC

 

3 (16%)

-46.6%

-14.35

24

SOC

 

1 (6%)

-39.2%

-5.27

36

TE (95% CI)

 

NR

Diff = -7.4 (-33.4 to 18.6); p=0.57

Diff = -9.08 (-19.23 to1.06); p=0.08

NR

 

 

At 7 Wk

Mean % Change In Wound Area at 4 Wk

Mean % Reduction in VAS Pain Score at 4 Wk

 

Gibbons et al (2015)13

N

 NR

81

81

81

NR

NLFU+SOC

 

11 (28%)

-61.6%

-80%

 

SOC

 

6 (15%)

-45.0%

-20%

 

TE (95% CI)

 

NR

Diff/CI NR; p=0.02

Diff/CI NR; p=0.01

 

 

 

At 14 Days 

 

Mean VAS Pain Scoreat 3 Wk

 

Prather et al (2015)14

N

NR 

NR

NR

NR

NR

NLFU+SOC

 12.1 d

92%

 

0.04

 

SOC

21.3 d 

64%

 

1.0

 

TE (95% CI)

HR/CI NR; p=0.04 

NR

 

NR

 

 

 

 

Mean Wound Size

Pain on 0-20 Scale

 

 

 

 

at 4 Mo

at 4 Mo

 

Olyaie et al (2013)11

N

90 

NR

90

90

NR

HFUS+SOC

6.86mo 

 

3.23 cm2

3.96

 

NLFU+SOC

6.65 mo 

 

2.72 cm2

3.26

 

SOC

8.50 mo 

 

4.28 cm2

5.10

 

TE (95% CI)

Diff/CI NR; between 3 groups p=0.001 

 

Diff/CI NR; between 3 groups p=0.02

Diff/CI NR; between 3 groups p=0.02

 

 

 

 

 

Pain on 0-20 Scale at 4 Mo

 

Beheshti et al (2014)10

90 

NR 

NR 

 

NR 

HFUS+SOC 

6.10 mo 

 

 

4.20 

 

NLFU+SOC 

5.70 mo 

 

 

4.20 

 

SOC 

8.13 mo 

 

 

6.56 

 

 TE (95% CI)

Diff/CI NR; p<0.001b

 

 

Diff/CI NR; p<0.001b

 

 

 

 

% With 50% Reduction in Wound Volume at 12 Wk

 

 

Kavros et al (2007)9 

 

 

 

 

 

NR 

NR 

 

NR 

NR 

NLFU+SOC 

 

 

63% 

 

 

SOC 

 

 

29% 

 

 

TE (95% CI) 

 

 

Ratio/CI NR; p<0.001 

 

 

 

 

At 10 Wk 

 

No. With Pain During Treatment, Pain Scale Not Described

% of Patients With Event 

Ennis et al (2005)6

55c 

133 

NR 

133 

133 

NLFU+SOC 

9.2 wk 

26% 

 

  • Mild: 51%
  • Moderate:41%
  • Severe: 7% 

SOC 

11.0 wk 

22% 

 

3

  • Mild:46%
  • Moderate: 39%
  • Severe: 15% 

TE (95%CI) 

HRNR; p<0.014 

Ratio/CI NR; p=0.69 

 

 

Ratios/CIs NR; p=0.27 

CI: confidence interval; Diff: difference; HFUS: high-frequency ultrasound; HR: hazard ratio; NLFU: noncontact low-frequency ultrasound; NR: not reported; RCT: randomized controlled trial; SOC: standard of care; TE: treatment effect; VAS: visual analog scale.
a Includes trials with ≥25 participants.
b  The comparison for this p-value is unclear.
c Per-protocol analysis. 

Limitations in the body of evidence are summarized in Tables 6 and 7 and the following paragraphs. In 2005, Ennis et al published findings of a double-blind, multicenter, sham-controlled trial of MIST therapy for recalcitrant diabetic foot ulcers in 133 patients.6 Patients with were treated with active or sham MIST therapy 3 times per week, with débridement as needed and a weekly evaluation by an independent investigator. Twenty-four patients were lost to follow-up, and data from 54 patients were excluded from analysis due to protocol violations (5 centers inverted the treatment distances for the active and sham devices), leaving 55 (41%) patients for the per-protocol analysis. Investigators reported significant improvement in the active treatment group (11/27 [41%] patients) compared with the control group (4/28 [14%] patients) in the proportion of wounds healed (defined as complete epithelialization without drainage). However, intention-to-treat analysis showed no difference in wound healing between the active (n=70 [26%]) and control (n= 63 [22%]) groups. In addition to the 59% loss to follow-up, there was a difference in the ulcer area at baseline (1.7 cm2 vs 4.4 cm2, respectively) and chronicity of wounds (35 weeks vs 67 weeks, respectively) that favored MIST therapy in the per-protocol groups. Due to the serious limitations of this trial, these results are considered inconclusive.

In the White et al (2016),12 Gibbons et al (2015),13 and Prather et al (2015)14 studies, patients, and providers were not blinded, but outcome assessment was blinded. The other studies did not mention blinding. All but one RCT reported improved (statistically significant) results for the primary outcome with NLFU than with standard of care. However, these studies had methodologic limitations. Regarding outcome assessment, complete healing is considered the most clinically relevant outcome.15 Complete healing was reported in a subset of the studies, and most were not powered for this outcome or the outcome used to power the study was unclear. Only Prather (2015)14 and Ennis (2005)6 conducted blinded outcome assessments and reported complete healing. Another limitation of the body of evidence is that some of the standard care interventions involved different visit schedules than the NLFU intervention, and the effects of this differential in face-to-face contact could partially explain the difference in findings between intervention and control groups.

Table 6. Relevance Gaps in RCTs 

Study

Population

Intervention

Comparator

Outcomes                

Follow-Up 

 

 

3. Follow-up schedule for SOC involved fewer visits than NLFU

3. Follow-up schedule for SOC involved fewer visits than NLFU

 

 

Gibbons et al (2015)13

 

 

 

3. Adverse events not reported

 

Prather et al (2015)14

 

 

1. Did not describe SOC

3. Adverse events not reported

 

Olyaie et al (2013)11

 

 

 

3. Adverse events not reported

 

Beheshti et al (2014)10

 

 

2. Only compression used

3. Details about frequency of SOC administration not provided

3. Adverse events not reported

 

Kavros et al (2007)9

 

 

3. Follow-up more intensive in SOC 

3. Follow-up more intensive in SOC 

1. Complete wound healing not reported

3.Adverse events not reported

 

Ennis etal (2005)6 

None noted 

None noted 

None noted 

None noted 

 

None noted

Key 

  1. Intended use population unclear
  2. Clinical context for test is unclear
  3. Study population unclear
  4. Study population not representative of intended use
  5. Study population is subpopulation of intended use 
  1. Not clearly defined
  2. Version used unclear
  3. Delivery not similar intensity as comparator 
  1. Not clearly defined
  2. Not standard or optimal
  3. Delivery not similar intensity as intervention
  4. Not delivered effectively 
  1. Key health outcomes not addressed
  2. Physiologic measures, not validated surrogates
  3. No CONSORT reporting of harms
  4. Not established and validated measurements
  5. Clinically significant difference not prespecified
  6. Clinically significant difference not supported 
  1.  Not sufficient duration for benefits
  2. Not sufficient duration for harms

 

NLFU: noncontact low-frequency ultrasound; SOC: standard of care 

Table 7. Study Design and Conduct Gaps in RCTs

Study Allocation Blinding Selective Reporting Folow-up Power Statistical
White et al (2016)12  
  1. Not blinded assignment
  2. Not blinded assessment
       

Gibbons et al (2015)13

 
  1. Not blinded assignment
  2. Not blinded assessment
       
Prather et al (2015)14  
  1. Not blinded assignment
  2. Not blinded assessment
       
Olyaie et al (2013)11  
  1. Not blinded assignment
  2. Not blinded assessment 
  1. Registration not documented in publication 
 
  1. No power calculations 
 
Beheshti et al (2014)1  
  1. Not blinded assignment
  2. Not blinded assessment 
  1. Registration not documented in publication 
 
  1. No power calculations 
 

Kavros et al (2007)9

 
  1. Not blinded assignment
  2. Not blinded assessment
 
  1. Registration not documented in publication 
 
  1. No power calculations 
 
Key6       1, 5. High number of protocol deviations and exclusions
  1. No power calculations
 
 
  1. Participants not randomly allocated
  2. Allocation not concealed
  3. Allocation concealment unclearInadequate control for selection bias
  1. Not blinded to treatment assignment
  2. Not blinded outcome assessment
  3. Outcome assessed by treating physician
  1. Not registered
  2. Evidence of selective reporting
  3. Evidence of selective publication
  1. High loss to follow-up or missing data
  2. Inadequate handling of missing data
  3. High number of crossovers
  4. Inadequate handling of crossovers
  5. Inappropriate exclusions
  6. Not intention-to- treat analysis (per-protocol for noninferiority trials)
  1. Power calculations not reported
  2. Power not calculated for primary outcome
  3. Power not based on clinically important difference
  1. Test is not appropriate for outcome type:Test is not appropriate for multiple observations per patient
    • continuous;
    • binary;
    • time to event
  2. Confidence intervals and/or p values not reported
  3. Comparative treatment effects not calculated

RCT: randomized controlled trials.

SUMMARY OF EVIDENCE
For individuals who have any wound type (acute or nonhealing) who receive noncontact ultrasound therapy plus standard wound care, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. The single double-blinded, sham-controlled randomized trial, which included patients with nonhealing diabetic foot ulcers, had substantial methodologic flaws (eg, high dropout rate, baseline differences between groups) that limit the validity of the findings. In the remaining studies comprising the evidence base, all but 1 RCT comparing NLFU with standard wound care reported improved (statistically significant) results on the primary outcome with NLFU. However, these studies also had several methodologic limitations. Complete healing is the most clinically relevant outcome. None of the RCTs evaluating venous leg ulcers reported complete healing as its primary outcome measure, and none had blinded outcome assessment. Only 1 RCT, which addressed split-thickness graft donor sites, reported on the proportion of patients with complete healing and had blinded outcome assessment. Another limitation of the body of evidence is that some standard of care interventions involved fewer visits than the NLFU intervention, and the differences in intensity of care resulting from this differential in face-to-face contact could partially explain the difference in findings between intervention and control groups. The evidence is insufficient to determine the effects of the technology on health outcomes.

PRACTICE GUIDELINES AND POSITION STATEMENTS 
Association for the Advancement of Wound Care
In 2010, the Association for the Advancement of Wound Care published guidelines on care of pressure ulcers.16 Noncontact low-frequency ultrasound therapy was included as a potential second-line intervention if first-line treatments did not result in wound healing.

The Association guidelines on the treatment of venous ulcers, updated in 2015, stated that low-frequency ultrasound treatment requires additional evidence before it can be considered an appropriate treatment.17

Society for Vascular Surgery, American Venous Forum, American Podiatric Medical Association
The Society for Vascular Surgery in collaboration with the American Venous Forum published joint guidelines on the management of venous leg ulcers in 2014.18 The guidelines recommended adjuvant wound therapy options for venous leg ulcers that fail to demonstrate improvement after 4 to 6 weeks of standard wound therapy (strength of recommendation: grade 1; quality of evidence: level B), but recommended against routine ultrasound therapy for venous leg ulcers (strength of recommendation: grade 2; quality of evidence: level B).

The Society for Vascular Surgery in collaboration with the American Podiatric Medical Association published joint guidelines on the management of diabetic foot in 2016.19 The guidelines recommended adjuvant therapy for diabetic foot ulcers that fail to demonstrate more than 50% wound area reduction after 4 weeks of standard wound therapy. The adjunctive wound therapy options listed in the guidelines included negative pressure therapy, biologics (platelet-derived growth factor, living cellular therapy, extracellular matrix products, amniotic membrane products), and hyperbaric oxygen therapy. Ultrasound therapy was not mentioned as a recommended adjuvant option. 

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
Not applicable. 

ONGOING AND UNPUBLISHED CLINICAL TRIALS
A search of ClinicalTrials.gov in December 2017 did not identify any ongoing or unpublished trials that would likely influence this review.

References:

  1. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for Treatment. Rockville, MD: Food and Drug Administration; 2006 June.
  2. Food and Drug Administration. MIST[TM] Therapy System: 510(k) Premarket Notification: K050129. https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050129.pdf. Accessed January 2, 2018.
  3. Food and Drug Administration. 510(k) Summary: 510(k) -AR1000 Series K131096, Arobella Medical, LLC. 2014; https://www.accessdata.fda.gov/cdrh_docs/pdf13/K131096.pdf. Accessed January 2, 2018.
  4. Tricco AC, Antony J, Vafaei A, et al. Seeking effective interventions to treat complex wounds: an overview of systematic reviews. BMC Med. Apr 22 2015;13:89. PMID 25899006
  5. Voigt J, Wendelken M, Driver V, et al. Low-frequency ultrasound (20-40 kHz) as an adjunctive therapy for chronic wound healing: a systematic review of the literature and meta-analysis of eight randomized controlled trials. Int J Low Extrem Wounds. Dec 2011;10(4):190-199. PMID 22184750
  6. Ennis WJ, Foremann P, Mozen N, et al. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. Aug 2005;51(8):24-39. PMID 16234574
  7. Peschen M, Weichenthal M, Schopf E, et al. Low-frequency ultrasound treatment of chronic venous leg ulcers in an outpatient therapy. Acta Derm Venereol. Jul 1997;77(4):311-314. PMID 9228227
  8. Chang YR, Perry J, Cross K. Low-frequency ultrasound debridement in chronic wound healing: a systematic review of current evidence. Plast Surg (Oakv). Feb 2017;25(1):21-26. PMID 29026808
  9. Kavros SJ, Miller JL, Hanna SW. Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo clinic experience, 2004-2006. Adv Skin Wound Care. Apr 2007;20(4):221-226. PMID 17415030
  10. Beheshti A, Shafigh Y, Parsa H, et al. Comparison of high-frequency and MIST ultrasound therapy for the healing of venous leg ulcers. Adv Clin Exp Med. Nov-Dec 2014;23(6):969-975. PMID 25618125
  11. Olyaie M, Rad FS, Elahifar MA, et al. High-frequency and noncontact low-frequency ultrasound therapy for venous leg ulcer treatment: a randomized, controlled study. Ostomy Wound Manage. Aug 2013;59(8):14-20. PMID 23934374
  12. White J, Ivins N, Wilkes A, et al. Non-contact low-frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single-centre, assessor-blinded, randomised controlled trial. Int Wound J. Oct 2016;13(5):833-842. PMID 25619411
  13. Gibbons GW, Orgill DP, Serena TE, et al. A prospective, randomized, controlled trial comparing the effects of noncontact, low-frequency ultrasound to standard care in healing venous leg ulcers. Ostomy Wound Manage. Jan 2015;61(1):16-29. PMID 25581604
  14. Prather JL, Tummel EK, Patel AB, et al. Prospective randomized controlled trial comparing the effects of noncontact low-frequency ultrasound with standard care in healing split-thickness donor sites. J Am Coll Surg. Aug 2015;221(2):309-318. PMID 25868409
  15. Gottrup F, Apelqvist J, Price P, et al. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care. Jun 2010;19(6):237-268. PMID 20551864
  16. Association for the Advancement of Wound Care (AAWC). Guideline of Pressure Ulcer Guidelines. 2010; https://s3.amazonaws.com/aawc-new/memberclicks/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf. Accessed January 2, 2018.
  17. Association for the Advancement of Wound Care (AAWC). International Consolidated Venous Ulcer Guideline (ICVUG) 2015 (Update of AAWC Venous Ulcer Guideline, 2005 and 2010). 2015; https://aawconline.memberclicks.net/assets/appendix%20c%20guideline%20icvug-textformatrecommendations- final%20v42%20changessaved18aug17.pdf. Accessed January 2, 2018.
  18. O'Donnell TF, Jr., Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. Aug 2014;60(2 Suppl):3s-59s. PMID 24974070
  19. Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. Feb 2016;63(2 Suppl):3s-21s. PMID 26804367

Coding Section

Codes Number Description
CPT  97610

Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day (new code 01/01/14) 

ICD-9-CM Diagnosis   Investigational for all diagnoses
ICD-10-CM (effective 10/1/15)   Investigational for all diagnoses
  E08.621, E08.622, E09.621, E09.622, E10.621, E10.622, E11.621, E11.622, E13621, E13.622 Various types of diabetes with skin complications (foot ulcer or other skin ulcer) code list
  I183.001-I83.029: I83.201-I83.229 Varicose veins with ulcer code range
  L00 - L08.9 Infections of the skin code range (includes cellulitis - L03
  L89.00-L89.95 Pressure ulcer code range
  L97.10-L97.929 Non-pressure chronic ulcer of skin code range
  L98.41-L98.499 Non-pressure chronic ulcer of skin not otherwise classified code range
  L99 Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
ICD-10-PCS (effective 10/1/15)   ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for the initiation or application of this therapy.
Type of Service     
Place of Service    

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

10/11/2018 

Annual review, no change to policy intent. Updating background, rationale and references. 

10/05/2017 

Annual review, no change to policy intent. Updating background, description, regulatory status, rationale and references. 

10/12/2016

Annual review, no change to policy intent. Updating background, description, guidelines, rationale and references. 

10/14/2015 

Annual review, no change to policy intent. Udpated background, description, regulatory status, rationale, references and coding. Added guidelines.

10/07/2014

Annual review. Updated rationale and references. Added related policy and coding section. No change to policy intent.


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