Status:
COMPLETED
Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers
Lead Sponsor:
Acera Surgical, Inc.
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 di...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04918784
Start Date
May 5 2021
End Date
December 1 2022
Last Update
September 28 2023
Active Locations (1)
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1
Midwest Foot and Ankle Clinics
Hoffman Estates, Illinois, United States, 60169