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

Acera Surgical

Status

Completed

Conditions

Diabetic Foot Ulcer

Treatments

Device: Restrata TM Wound Matrix

Study type

Interventional

Funder types

Industry

Identifiers

NCT03312595

17-RES-001

Details and patient eligibility

About

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).

Full 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

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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