Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human subjects.

Key facts

Study ID: NCT04918784
Run by: Acera Surgical, Inc.
People needed: 46
Starts: 2021-05-05
Expected to finish: 2022-12-01
Last updated by the study team: 2023-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is at least 18 years old
Patient is willing and capable of complying with all protocol requirements
Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to or at the beginning of the run-in period
Patient has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)
Ulcer must be located at least in part on the foot or ankle
Ulcer must be present for a minimum of 28 days prior to randomization and initial application of study product
Wound size must be < 30cm2 on the day of randomization and initial application of the study product, after initial debridement
Patient has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
Dorsum transcutaneous oxygen test (TcPO2) of study leg with results ≥40mmHg, OR
Ankle-Brachial Index (ABI) of study leg with results of ≥ 0.7
Toe-Brachial Index (TBI) of study extremity with results of > 50 mmHg

You may not qualify if…

Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint
Patient is pregnant, breast feeding or planning to become pregnant
Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
Patient has a life expectancy less than six months as assessed by the investigator
Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period
Patient has an additional wound within 3 cm of the study wound
Hgb A1c > 12% within 3 months prior to randomization in patients with a known history of diabetes
Patient not in reasonable metabolic control in the judgment of the investigator
Patient with a known history of poor compliance with medical treatments
Patient currently undergoing cancer treatment
Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period. Chronic oral steroid use is not excluded if dose is < 10 mg per day for prednisone.
Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgment of the investigator
Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
Patient unwilling to or unable to safely utilize appropriate offloading device to unweight wound
Study ulcer spontaneously closes during the 2-week run in period

Where it is running

Midwest Foot and Ankle Clinics — Hoffman Estates, Illinois, United States

Full record on ClinicalTrials.gov

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