Diabetic WoundPhase 4NCT04405050
RCT to Compare Restrata and NPWT to Heal Complex DFUs
A Phase 4 study testing Restrata and Negative Pressure Wound Therapy (NPWT) in people with Diabetic Wound, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of Restrata compared to Negative Pressure Wound Therapy (NPWT) to heal complex diabetic foot wounds. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetic Wound
- What is being tested?
- Restrata and Negative Pressure Wound Therapy (NPWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2021to Jul 2023
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a diabetes mellitus
- Men/women ≥21 years old
- Post-operative foot or ankle wounds sized < 15cm
- ABI ≥0.5 or toe pressures >30 mmHg
- Wounds indicated for treatment with NPWT
Who cannot join
- Active Charcot arthropathy
- Unable to use NPWT at home
- Untreated bone or soft tissue infection
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
- Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
- Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials. Active alcohol (> 14 drinks per week over the last 3 months) or substance abuse (current use of cocaine, heroin, or methamphetamines or if drug or alcohol use will interfere with follow-up visits in foot clinic in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
About this study
Official title: Randomized Clinical Trial to Compare Restrata and Negative Pressure Wound Therapy (NPWT) to Heal Complex Diabetic Foot Wounds
The purpose of this study is to compare the efficacy of Restrata compared to Negative Pressure Wound Therapy (NPWT) to heal complex diabetic foot wounds.
Read the detailed description
Screening
- Explain purpose and nature of the study and obtain signature on the informed consent document.
- Screen the subject against protocol inclusion and exclusion criteria, including all pertinent tests, including pregnancy test if needed.
Baseline (may be done as same day as screening procedures)
- Obtain general medical history and demographic information and social history
- Complete a physical examination, body weight, height, and vital signs, including measurement of resting heart rate, respiratory rate, and blood pressure while seated.
- Select target study ulcer
- Obtain complete history pertinent to DFU disease including duration of the target ulcer, previous and current treatment.
- Perform debridement and obtain tissue collection (3 tissue and 1 bone if applicable).
- Perform standardized photography and measurement of the study wound (eKare or available camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device (eKare, Fairfax, VA).
- Perform hyperspectral imaging of dorsal and plantar aspects of the foot.
- Perform neuropathy assessment (monofilament, VPT)
- Skin perfusion pressure (Sensilase)
- Collect all relevant concomitant medication (antibiotics, steroids, and diabetes medications)
- Complete questionnaires
- Place Restrata and dress wound or apply NPWT therapy.
- Submit subject stipend
Therapy/Treatment Phase
Study Visit 1-11:
- Assess target ulcer (if wound has closed, document as such, skip to END OF STUDY VISIT (EOS).
- Document time on/off NPWT if applicable.
- If Restrata is removed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device - if the wound is deemed healed by the physician, skip to EOS visit.
- Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or healed.
- Debride wound if indicated. Re-measure wound if surgical debridement is performed prior to dressing the wound
- Collect all relevant concomitant medication.
- If wound is not healed, redress the wound with Restrata dressing (if removed for debridement) or NPWT.
- Disburse subject stipend
- Note: at week 3, if wound is not ready for surgical closure, remove Restrata and replace with new piece of Restrata (per randomization schedule)
- Assess for AE/SAEs and/or follow up on previous AE/SAEs.
Study Visit Closed
- When a study wound has closed, we will perform the EOS evaluation.
- If a wound has closed, the patient will enter the follow-up phase of the study.
Study Visit 12/EOS:
- If the study wound closes prior to the 12-week study mark, subjects will perform EOS visit at the time of wound closure.
- Assess target ulcer.
- If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device.
- Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or healed.
- If wound has not closed, redress the wound per physician-directed standard of care.
- Perform EOS visit documentation
- Complete questionnaires
- Follow up on AE/SAEs that have not yet been resolved.
Study Visit Follow-up
- If the wound heals during the treatment phase or if the wound is not healed after 12 weeks, data from their electronic medical record will be evaluated to identify healing, time to heal, adverse events related to the wound.
- Conditions
- Diabetic Wound
- Being tested
- Restrata, Negative Pressure Wound Therapy (NPWT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestrataDevice
Restrata® is a novel synthetic nanofabricated scaffold (Restrata Wound Matrix (RWM), Acera Surgical, St. Louis, Missouri) has been developed which is a sterile, single-use device intended for use in the local management of wounds. The RWM is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur (Figure 2). The RWM is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native ECM. As a viable wrap for surgical procedures, Restrata conforms to injured tissue, can be sutured, and is arthroscopic and robotic procedure friendly.
Negative Pressure Wound Therapy (NPWT)Device
Negative Pressure Wound Therapy (NPWT) has dramatically changed the care of complex foot wounds. Compared to standard wound care, patients with diabetic foot wounds that are treated with NPWT are 5.9 times more likely to heal and 4.4 times less likely to require amputation. NPWT involves the delivery of sub-atmospheric pressure through a vacuum pump connected to a specialized dressing to maintain a closed environment. NPWT increases perfusion to the wound, accelerates granulation tissue formation, reduces edema, and reduces bio-burden
| Study group | Role | What they receive |
|---|---|---|
| Restrata | Active comparator | Treated with Restrata Receives: Device: Restrata |
| NPWT | Active comparator | Treated with NPWT (Negative Pressure Wound Therapy) Receives: Device: Negative Pressure Wound Therapy (NPWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
The primary objective of this trial is to evaluate the incidence of wound closure. Closure is defined as complete epithelialization with no drainage.
Measured: 12 weeks
Secondary outcomes (2)
Time to wound healing
Days to complete closure. Closure is defined as complete epithelialization with no drainage.
Measured: 12 weeks
Differences in wound healing trajectories
Defined as the change in wound area per week. Measured by wound measuring camera and PI observation/physical exam. Reported as mm^2 per day.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study startJun 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Project Never Initiated - no human subjects were enrolled and no data regarding humans was collected or studied.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic WoundStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare Restrata and NPWT in patients with complex diabetic foot ulcers.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Acera Surgical, Inc.
- Responsible party
- Principal investigator, Larry Lavery, University of Texas Southwestern Medical Center
- Investigators
- Lawrence Lavery, DPM MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405050
- Sponsor's protocol ID
- 2020-0268
- Status last verified
- Jul 2023
- First submitted
- 22 May 2020
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Compare Restrata and Negative Pressure Wound Therapy (NPWT) to Heal Complex Diabetic Foot Wounds
- ClinicalTrials.gov ID
- NCT04405050
- Acronym / sponsor ID
- 2020-0268
- Conditions
- Diabetic Wound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project Never Initiated - no human subjects were enrolled and no data regarding humans was collected or studied.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Acera Surgical, Inc.
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 28 May 2020 (actual)
- 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 compare the efficacy of Restrata compared to Negative Pressure Wound Therapy (NPWT) to heal complex diabetic foot wounds.
Detailed description
Screening
- Explain purpose and nature of the study and obtain signature on the informed consent document.
- Screen the subject against protocol inclusion and exclusion criteria, including all pertinent tests, including pregnancy test if needed.
Baseline (may be done as same day as screening procedures)
- Obtain general medical history and demographic information and social history
- Complete a physical examination, body weight, height, and vital signs, including measurement of resting heart rate, respiratory rate, and blood pressure while seated.
- Select target study ulcer
- Obtain complete history pertinent to DFU disease including duration of the target ulcer, previous and current treatment.
- Perform debridement and obtain tissue collection (3 tissue and 1 bone if applicable).
- Perform standardized photography and measurement of the study wound (eKare or available camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device (eKare, Fairfax, VA).
- Perform hyperspectral imaging of dorsal and plantar aspects of the foot.
- Perform neuropathy assessment (monofilament, VPT)
- Skin perfusion pressure (Sensilase)
- Collect all relevant concomitant medication (antibiotics, steroids, and diabetes medications)
- Complete questionnaires
- Place Restrata and dress wound or apply NPWT therapy.
- Submit subject stipend
Therapy/Treatment Phase
Study Visit 1-11:
- Assess target ulcer (if wound has closed, document as such, skip to END OF STUDY VISIT (EOS).
- Document time on/off NPWT if applicable.
- If Restrata is removed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device - if the wound is deemed healed by the physician, skip to EOS visit.
- Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or healed.
- Debride wound if indicated. Re-measure wound if surgical debridement is performed prior to dressing the wound
- Collect all relevant concomitant medication.
- If wound is not healed, redress the wound with Restrata dressing (if removed for debridement) or NPWT.
- Disburse subject stipend
- Note: at week 3, if wound is not ready for surgical closure, remove Restrata and replace with new piece of Restrata (per randomization schedule)
- Assess for AE/SAEs and/or follow up on previous AE/SAEs.
Study Visit Closed
- When a study wound has closed, we will perform the EOS evaluation.
- If a wound has closed, the patient will enter the follow-up phase of the study.
Study Visit 12/EOS:
- If the study wound closes prior to the 12-week study mark, subjects will perform EOS visit at the time of wound closure.
- Assess target ulcer.
- If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device.
- Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or healed.
- If wound has not closed, redress the wound per physician-directed standard of care.
- Perform EOS visit documentation
- Complete questionnaires
- Follow up on AE/SAEs that have not yet been resolved.
Study Visit Follow-up
- If the wound heals during the treatment phase or if the wound is not healed after 12 weeks, data from their electronic medical record will be evaluated to identify healing, time to heal, adverse events related to the wound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare Restrata and NPWT in patients with complex diabetic foot ulcers.
| Arm | Type | Receives |
|---|---|---|
| Restrata | Active comparator | Device: RestrataTreated with Restrata |
| NPWT | Active comparator | Device: Negative Pressure Wound Therapy (NPWT)Treated with NPWT (Negative Pressure Wound Therapy) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of a diabetes mellitus
- Men/women ≥21 years old
- Post-operative foot or ankle wounds sized < 15cm
- ABI ≥0.5 or toe pressures >30 mmHg
- Wounds indicated for treatment with NPWT
Key exclusion criteria (7 listed)
- Active Charcot arthropathy
- Unable to use NPWT at home
- Untreated bone or soft tissue infection
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
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 |
|---|---|---|
| RestrataRestrata® is a novel synthetic nanofabricated scaffold (Restrata Wound Matrix (RWM), Acera Surgical, St. Louis, Missouri) has been developed which is a sterile, single-use device intended for use in the local management of wounds. The RWM is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur (Figure 2). The RWM is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native ECM. As a viable wrap for surgical procedures, Restrata conforms to injured tissue, can be sutured, and is arthroscopic and robotic procedure friendly. | Device | Restrata |
| Negative Pressure Wound Therapy (NPWT)Negative Pressure Wound Therapy (NPWT) has dramatically changed the care of complex foot wounds. Compared to standard wound care, patients with diabetic foot wounds that are treated with NPWT are 5.9 times more likely to heal and 4.4 times less likely to require amputation. NPWT involves the delivery of sub-atmospheric pressure through a vacuum pump connected to a specialized dressing to maintain a closed environment. NPWT increases perfusion to the wound, accelerates granulation tissue formation, reduces edema, and reduces bio-burden | Device | NPWT |
Primary outcome
Wound Closure
Time frame: 12 weeks
The primary objective of this trial is to evaluate the incidence of wound closure. Closure is defined as complete epithelialization with no drainage.
2 secondary outcomes
Time to wound healing
Time frame: 12 weeks
Differences in wound healing trajectories
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Diabetic Wound
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
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.
Lawrence Lavery, DPM MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Restrata and Negative Pressure Wound Therapy (NPWT) in people with Diabetic Wound, run by University of Texas Southwestern Medical Center 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 24 Jul 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Wound Closure (time frame: 12 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 24 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.