RCT to Compare Restrata and NPWT to Heal Complex DFUs
Primary Purpose
Diabetic Wound
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Restrata
Negative Pressure Wound Therapy (NPWT)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Wound
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- UT Southwestern Medical Center at Dallas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Restrata
NPWT
Arm Description
Treated with Restrata
Treated with NPWT (Negative Pressure Wound Therapy)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to wound healing
Days to complete closure. Closure is defined as complete epithelialization with no drainage.
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.
Full Information
NCT ID
NCT04405050
First Posted
May 22, 2020
Last Updated
July 20, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Acera Surgical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04405050
Brief Title
RCT to Compare Restrata and NPWT to Heal Complex DFUs
Official Title
Randomized Clinical Trial to Compare Restrata and Negative Pressure Wound Therapy (NPWT) to Heal Complex Diabetic Foot Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Project Never Initiated - no human subjects were enrolled and no data regarding humans was collected or studied.
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Acera Surgical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
1. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Restrata
Arm Type
Active Comparator
Arm Description
Treated with Restrata
Arm Title
NPWT
Arm Type
Active Comparator
Arm Description
Treated with NPWT (Negative Pressure Wound Therapy)
Intervention Type
Device
Intervention Name(s)
Restrata
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Negative Pressure Wound Therapy (NPWT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Wound Closure
Description
The primary objective of this trial is to evaluate the incidence of wound closure. Closure is defined as complete epithelialization with no drainage.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Time to wound healing
Description
Days to complete closure. Closure is defined as complete epithelialization with no drainage.
Time Frame
12 weeks
Title
Differences in wound healing trajectories
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Lavery, DPM MPH
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RCT to Compare Restrata and NPWT to Heal Complex DFUs
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