Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)

Not Applicable

Completed

Conditions: Diabetic Foot Ulcer

Interventions: Device: Restrata TM Wound Matrix

Registration Number: NCT03312595

Lead Sponsor: Acera Surgical, Inc.

Brief 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).

Detailed Description: Control Group: None (Utilize historical / published data on outcomes using standard of care)

Test Group: Treatment of DFUs with RestrataTM Wound Matrix

Study Type: Interventional

Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy Intervention Model: Direct assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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 < 12%
- Serum Creatinine < 3.0mg/dl
Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days of the first screening visit:
- Dorsum transcutaneous oxygen test (TcPO2) with results
  
  ≥30mmHg, OR
- ABIs with results of ≥0.7 and ≤1.5, OR
- Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg

Exclusion Criteria

Patients presenting with an ulcer probing to bone (UT Grade IIIA-D)
Patients whose index diabetic foot ulcers are greater than 25cm2
Patient has an additional wound within 3cm of the study wound
Patients not in reasonable metabolic control
Patients with a known history of poor compliance with medical treatments
Patients who have been previously enrolled into this study, or are presently participating in a clinical trial with DFU indications
Patients with known or suspected local skin malignancy to the index diabetic ulcer
Patients diagnosed with autoimmune connective tissues diseases
Patients that have received a graft material on the study ulcer within the previous 30 days
Patients who are pregnant or breast feeding
Patients who are taking medications that are considered immune system modulator
Study wound has closed > 30% over the two-week run-in period
Patients with a known allergy to resorbable suture materials

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Restrata TM Wound Matrix	Restrata TM Wound Matrix	Prospective, single armed, non-randomized study with direct assignment

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Wound Closed	Up to 14 weeks	from baseline at week 0 to 14 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Wound Area From Baseline	Baseline and weekly for up to 14 weeks	Wound area measurements will be made via tracing acetate every week for 14 weeks.
Time to Wound Closure	Baseline up to 14 weeks	The number of weeks until complete closure is first identified will be determined for each patient who has been deemed completely closed within the 14 week treatment period.

Trial Locations

Locations (5): Arizona Reginal Medical Research
🇺🇸
Tucson, Arizona, United States
SAVAHCS
🇺🇸
Tucson, Arizona, United States
Associated Foot & Ankle Specialists
🇺🇸
Phoenix, Arizona, United States
Richard C. Galperin, DPM
🇺🇸
Dallas, Texas, United States
Advanced Foot Care And Clinical Research Center
🇺🇸
Fresno, California, United States