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

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Wound Dressing; Device: Restrata®

• Registration Number: NCT04918784
• Lead Sponsor: Acera Surgical, Inc.

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 diabetic foot ulcers in human subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-05
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-09
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-01
• Results First Submitted: 2023-08-01
• Results First Submitted QC: 2023-08-28
• Status Verified: 2023-09
• Results First Posted: 2023-09-21
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Patient is at least 18 years old

2. Patient is willing and capable of complying with all protocol requirements

3. Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to or at the beginning of the run-in period

4. Patient has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)

5. Ulcer must be located at least in part on the foot or ankle

6. Ulcer must be present for a minimum of 28 days prior to randomization and initial application of study product

7. Wound size must be < 30cm2 on the day of randomization and initial application of the study product, after initial debridement

8. Patient has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:

   1. Dorsum transcutaneous oxygen test (TcPO2) of study leg with results ≥40mmHg, OR
   2. Ankle-Brachial Index (ABI) of study leg with results of ≥ 0.7
   3. Toe-Brachial Index (TBI) of study extremity with results of > 50 mmHg

Exclusion Criteria

1. 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
2. Patient is pregnant, breast feeding or planning to become pregnant
3. Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
4. Patient has a life expectancy less than six months as assessed by the investigator
5. Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period
6. Patient has an additional wound within 3 cm of the study wound
7. Hgb A1c > 12% within 3 months prior to randomization in patients with a known history of diabetes
8. Patient not in reasonable metabolic control in the judgment of the investigator
9. Patient with a known history of poor compliance with medical treatments
10. Patient currently undergoing cancer treatment
11. Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
12. 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.
13. Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgment of the investigator
14. Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
15. Patient unwilling to or unable to safely utilize appropriate offloading device to unweight wound
16. Study ulcer spontaneously closes during the 2-week run in period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Standard of Care	Wound Dressing	Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Treatment with Synthetic Hybrid-Scale Fiber Matrix	Restrata®	Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.

Primary Outcome Measures

Name	Time	Method
Number of Participants With 100% Re-epithelialization	12 weeks	Primary outcome is number of participants with 100% epithelialization at 12 weeks of treatment as determined by investigator assessment of the ulcer and imaging.

Secondary Outcome Measures

Name	Time	Method
Time to Wound Closure	Up to 12 Weeks	The number of weeks from initial application of study treatment until complete re-epithelialization is first identified.
Change in Wound Area	12 weeks	The difference in wound area from baseline to 100% re-epithelialization or week 12 will be summarized for each treatment group in each arm. Wound sizes were documented by the investigator at baseline to end of the treatment period for each participant.
Number of Treatment Applications	12 weeks	The number of study treatment applications including the initial application until 12 weeks or until complete re-epithelialization, whichever occurs first.

Trial Locations

Locations (1)

Midwest Foot and Ankle Clinics; 🇺🇸 Hoffman Estates, Illinois, United States