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

NCT ID: NCT04918784

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2022-12-01

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment with Synthetic Hybrid-Scale Fiber Matrix

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.

Group Type: EXPERIMENTAL

Restrata®

Intervention Type: DEVICE

Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.

Treatment with Standard of Care

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.

Group Type: ACTIVE_COMPARATOR

Wound Dressing

Intervention Type: DEVICE

Alginate or Foam wound dressing is intended to manage wounds.

Interventions

Restrata®

Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.

Intervention Type: DEVICE

Wound Dressing

Alginate or Foam wound dressing is intended to manage wounds.

Intervention Type: DEVICE

Other Intervention Names

Synthetic Hybrid-Scale Fiber Matrix

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acera Surgical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khalid Husain, DPM

Role: PRINCIPAL_INVESTIGATOR

Midwest Foot & Ankle Clinics

Locations

Midwest Foot and Ankle Clinics

Hoffman Estates, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

21-RES-002

Identifier Type: -

Identifier Source: org_study_id