Diabetic Foot UlcerNCT03041844
Enhanced Ultrasound Treatment of Chronic Wounds With Monitoring of Healing and Quality of Life Outcomes
A study testing Low Frequency, Low Intensity Ultrasound in people with Diabetic Foot Ulcer and Venous Ulcer, run by Drexel University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of low frequency, low intensity ultrasound treatment on wound healing and health-related quality of life with a randomized clinical trial of patients with venous ulcers or diabetic ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Ulcer
- What is being tested?
- Low Frequency, Low Intensity Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a venous ulcer (VU) or diabetic ulcer (DU) that has been documented for at least 8 weeks without complete re-epithelialization and is larger than 0.75 cm2 in size.
- VUs must be present on the lower extremities non-weight-bearing areas.
- DUs must be present on the ankle or foot and be secondary to complications from diabetes.
- Patients with DUs must have a documented history of diabetes mellitus of at least six months.
Who cannot join
- VUs secondary to any connective tissue disorder or blood dyscrasias.
- Severe vascular insufficiency (ankle-brachial index lower than 0.75 or toe-brachial index below 0.5).
- Active, untreated infection
- Acute deep venous thrombosis
- Cutaneous malignancy present on the involved extremity
- Active (or past 6 months) cancer treatment
Show all 13Show fewer
- Presence of both a diabetic ulcer and a venous ulcer on the same extremity
- Known allergy to Tegaderm (a polyurethane dressing)
- Pregnant women
- Individuals younger than 18 years of age regardless of emancipation status
- Prisoners
- Individuals unable to speak English, Spanish, or Mandarin
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
About this study
The purpose of this study is to evaluate the effect of low frequency, low intensity ultrasound treatment on wound healing and health-related quality of life with a randomized clinical trial of patients with venous ulcers or diabetic ulcers.
Read the detailed description
The two most common types of chronic wounds are venous ulcers (VUs) and diabetic ulcers (DUs). The investigators will conduct the first double-blind randomized controlled trial (RCT) to test the effect of low-frequency, low-intensity (LFLI) ultrasound (US) on chronic wound healing and health related quality of life (HRQOL) with high statistical confidence (α < 0.05, power > 0.90, n=60 VUs, n=60 DUs). The investigators' approach combines this active therapy with non-invasive diagnostic monitoring of wound hemodynamics throughout the treatment cycle, and includes analysis of the impact of nutritional status and inflammation on wound closure. There are several innovative aspects of this work. Specifically, (1) The lightweight, battery-powered applicator is the first potentially wearable ultrasound wound therapy device that is safe to apply for extended periods of time. (2) The applicator actively promotes healing, which is fundamentally different from commercial ultrasonic systems that remove necrotic tissue only. (3) The study approach will link LFLI US exposure to changes in wound hemodynamics and HRQOL, which has the potential to enable personalized medicine. (4) The analysis of patient nutritional and systemic inflammatory status may enable further treatment customization by identifying those patients most likely to benefit from LFLI US therapy. (5) The study approach incorporates both disease-specific and generic measures of HRQOL, which is unique for a therapeutic ultrasound RCT.
The low-frequency, low-intensity (20 kiloHertz (kHz), <100 milliWatt per square centimeter (mW/cm2) spatial peak-temporal peak), portable ultrasound applicator is lightweight (<25g) and permits safe and clinically pragmatic wound treatment. The field parameters of the US device were previously optimized for venous ulcers, and three recent pilot clinical human studies (VUs: n=20, n=25; DUs: n=10) demonstrated that the treatment improved healing by 15% per week compared to sham treatment. The investigators therefore anticipate that our treatment will accelerate closure of chronic wounds, and hypothesize that (1) LFLI US will improve generic and disease-specific HRQOL scores, (2) LFLI US will activate beneficial changes in the microvasculature of the wound and surrounding tissue, and (3) individuals with poor nutrition and high levels of inflammation will have delayed wound healing.
The specific aims are to: (1) Assess the effect of LFLI US on VUs and DUs by measuring wound closure as a primary endpoint and generic and disease-specific HRQOL as secondary endpoints. (2) Monitor the effects of LFLI US on wound perfusion and oxygenation using non-invasive optical methods, and (3) Determine the impact of nutritional status and inflammation on closure of DUs and VUs. Overall, this work will validate LFLI US as a safe, portable, and cost-effective therapy for chronic wounds. This is important because new therapies and improved clinical paradigms for wound management are urgently needed. Over the long-term, the study findings may enable the development of personalized wound treatment regimens across care settings.
- Conditions
- Diabetic Foot Ulcer, Venous Ulcer
- Being tested
- Low Frequency, Low Intensity Ultrasound, Sham Applicator
- Keywords
- therapeutic ultrasound, quality of life
- Medical subject headings
- Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Frequency, Low Intensity UltrasoundDevice
Therapeutic ultrasound (20 kHz, <100 mW/cm2 spatial peak-temporal peak)
Sham ApplicatorDevice
Sham ultrasound applicator
| Study group | Role | What they receive |
|---|---|---|
| Low Frequency, Low Intensity Ultrasound | Experimental | Low Frequency, Low Intensity therapeutic ultrasound applied weekly for up to 16 weeks. Receives: Device: Low Frequency, Low Intensity Ultrasound |
| Sham Ultrasound | Sham comparator | Sham ultrasound applied weekly for up to 16 weeks. Receives: Device: Sham Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound size
Percentage change in wound size over 4 weeks
Measured: 4 weeks
Secondary outcomes (5)
Wound closure
Complete wound closure at 16 weeks
Measured: 16 weeks
Health Related Quality of Life (HRQOL)
Short form health survey will be administered to assess changes in HRQOL
Measured: 16 weeks, then 6 and 12 months after last treatment
Wound Quality of Life (WQOL)
Health survey will be administered to assess changes in wound-related HRQOL
Measured: 16 weeks
Wound oxyhemoglobin concentration change
Change in wound oxyhemoglobin concentration per week, measured with diffuse near infrared spectroscopy (DNIRS)
Measured: 16 weeks
Microcirculatory blood flow index change
Change in microcirculatory blood flow index per week, measured with diffuse correlation spectroscopy (DCS)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2022
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Temple University
- Responsible party
- Sponsor
- Investigators
- Peter A Lewin, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041844
- Sponsor's protocol ID
- 1609004864
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2017
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Ultrasound Treatment of Chronic Wounds With Monitoring of Healing and Quality of Life Outcomes
- ClinicalTrials.gov ID
- NCT03041844
- Acronym / sponsor ID
- 1609004864
- Conditions
- Diabetic Foot Ulcer, Venous Ulcer
- Keywords
- therapeutic ultrasound, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Temple University
- Study start
- Jan 2017
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2023 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of low frequency, low intensity ultrasound treatment on wound healing and health-related quality of life with a randomized clinical trial of patients with venous ulcers or diabetic ulcers.
Detailed description
The two most common types of chronic wounds are venous ulcers (VUs) and diabetic ulcers (DUs). The investigators will conduct the first double-blind randomized controlled trial (RCT) to test the effect of low-frequency, low-intensity (LFLI) ultrasound (US) on chronic wound healing and health related quality of life (HRQOL) with high statistical confidence (α < 0.05, power > 0.90, n=60 VUs, n=60 DUs). The investigators' approach combines this active therapy with non-invasive diagnostic monitoring of wound hemodynamics throughout the treatment cycle, and includes analysis of the impact of nutritional status and inflammation on wound closure. There are several innovative aspects of this work. Specifically, (1) The lightweight, battery-powered applicator is the first potentially wearable ultrasound wound therapy device that is safe to apply for extended periods of time. (2) The applicator actively promotes healing, which is fundamentally different from commercial ultrasonic systems that remove necrotic tissue only. (3) The study approach will link LFLI US exposure to changes in wound hemodynamics and HRQOL, which has the potential to enable personalized medicine. (4) The analysis of patient nutritional and systemic inflammatory status may enable further treatment customization by identifying those patients most likely to benefit from LFLI US therapy. (5) The study approach incorporates both disease-specific and generic measures of HRQOL, which is unique for a therapeutic ultrasound RCT.
The low-frequency, low-intensity (20 kiloHertz (kHz), <100 milliWatt per square centimeter (mW/cm2) spatial peak-temporal peak), portable ultrasound applicator is lightweight (<25g) and permits safe and clinically pragmatic wound treatment. The field parameters of the US device were previously optimized for venous ulcers, and three recent pilot clinical human studies (VUs: n=20, n=25; DUs: n=10) demonstrated that the treatment improved healing by 15% per week compared to sham treatment. The investigators therefore anticipate that our treatment will accelerate closure of chronic wounds, and hypothesize that (1) LFLI US will improve generic and disease-specific HRQOL scores, (2) LFLI US will activate beneficial changes in the microvasculature of the wound and surrounding tissue, and (3) individuals with poor nutrition and high levels of inflammation will have delayed wound healing.
The specific aims are to: (1) Assess the effect of LFLI US on VUs and DUs by measuring wound closure as a primary endpoint and generic and disease-specific HRQOL as secondary endpoints. (2) Monitor the effects of LFLI US on wound perfusion and oxygenation using non-invasive optical methods, and (3) Determine the impact of nutritional status and inflammation on closure of DUs and VUs. Overall, this work will validate LFLI US as a safe, portable, and cost-effective therapy for chronic wounds. This is important because new therapies and improved clinical paradigms for wound management are urgently needed. Over the long-term, the study findings may enable the development of personalized wound treatment regimens across care settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Frequency, Low Intensity Ultrasound | Experimental | Device: Low Frequency, Low Intensity UltrasoundLow Frequency, Low Intensity therapeutic ultrasound applied weekly for up to 16 weeks. |
| Sham Ultrasound | Sham comparator | Device: Sham ApplicatorSham ultrasound applied weekly for up to 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a venous ulcer (VU) or diabetic ulcer (DU) that has been documented for at least 8 weeks without complete re-epithelialization and is larger than 0.75 cm2 in size.
- VUs must be present on the lower extremities non-weight-bearing areas.
- DUs must be present on the ankle or foot and be secondary to complications from diabetes.
- Patients with DUs must have a documented history of diabetes mellitus of at least six months.
Key exclusion criteria (13 listed)
- VUs secondary to any connective tissue disorder or blood dyscrasias.
- Severe vascular insufficiency (ankle-brachial index lower than 0.75 or toe-brachial index below 0.5).
- Active, untreated infection
- Acute deep venous thrombosis
- Cutaneous malignancy present on the involved extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Frequency, Low Intensity UltrasoundTherapeutic ultrasound (20 kHz, <100 mW/cm2 spatial peak-temporal peak) | Device | Low Frequency, Low Intensity Ultrasound |
| Sham ApplicatorSham ultrasound applicator | Device | Sham Ultrasound |
Primary outcome
Change in wound size
Time frame: 4 weeks
Percentage change in wound size over 4 weeks
5 secondary outcomes
Wound closure
Time frame: 16 weeks
Health Related Quality of Life (HRQOL)
Time frame: 16 weeks, then 6 and 12 months after last treatment
Wound Quality of Life (WQOL)
Time frame: 16 weeks
Wound oxyhemoglobin concentration change
Time frame: 16 weeks
Microcirculatory blood flow index change
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Lewin, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Frequency, Low Intensity Ultrasound in people with Diabetic Foot Ulcer and Venous Ulcer, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound size (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.