N/A
N=30
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
Diabetic Foot Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03312595 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Percentage of Participants With Wound Closed — 75 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restrata TM Wound Matrix (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acera Surgical, Inc.
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Wound Closed |
75 | — |
| SECONDARY Change in Wound Area From Baseline |
96 | — |
| SECONDARY Time to Wound Closure |
6.4 | — |
Summary
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™). Results of this study may be used to make decisions on whether to conduct additional studies on this particular wound matrix product. RestrataTM has been cleared by the Food and Drug Administration for use in certain types of ulcer treatments, including the type that will be part of this study (diabetic foot ulcers).
Eligibility Criteria
Inclusion Criteria
- Male or female age 18 or older
- Patient's ulcer must be diabetic in origin, located at least in part on the plantar surface and larger than 1cm2 after the run-in period. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement
- Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two-week run in period will precede enrollment/randomization in the trial to document the indolent nature of the patients selected
- Patient does not exhibit clinical signs / symptoms of infection upon gross observation (at least 3 of the following: pain, redness, purulence, exudate, temperature) or have been diagnosed with an active infection at time of screening
- Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study
- Patient has adequate control of diabetes, as demonstrated by one of the following within 30 days of screening:
- HbA1c 30% over the two-week run-in period
- Patients with a known allergy to resorbable suture materials
Data sourced from ClinicalTrials.gov (NCT03312595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.