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

NCT04918784 | Completed Results FDA Device

• 1 other identifier: 21-RES-002
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

Synthetic Hybrid-Scale Fiber Matrix; Diabetic Foot Ulcer; Epithelialization

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 100% Re-epithelialization

  Primary outcome is number of participants with 100% epithelialization at 12 weeks of treatment as determined by investigator assessment of the ulcer and imaging.

  12 weeks

Secondary Outcomes (3)

• Change in Wound Area

  12 weeks

• Time to Wound Closure

  Up to 12 Weeks

• Number of Treatment Applications

  12 weeks

Other Outcomes (3)

• Quality of Life - SF-36

  12 weeks

• Cost Effectiveness / Economic Model

  12 weeks

• Incidence of Adverse Events

  12 weeks

Study Arms (2)

Treatment with Synthetic Hybrid-Scale Fiber Matrix

EXPERIMENTAL

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.

Device: Restrata®

Treatment with Standard of Care

ACTIVE COMPARATOR

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.

Device: Wound Dressing

Interventions

Restrata® 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.

Also known as: Synthetic Hybrid-Scale Fiber Matrix

Treatment with Synthetic Hybrid-Scale Fiber Matrix

Wound Dressing DEVICE

Alginate or Foam wound dressing is intended to manage wounds.

Treatment with Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Acera Surgical, Inc.: lead

Study Sites (1)

Midwest Foot and Ankle Clinics

Hoffman Estates, Illinois, 60169, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Bandages

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Matthew MacEwan
• Organization: Acera Surgical, Inc.

macewan@acera-surgical.com

440-477-1890

Study Officials

• Khalid Husain, DPM

  Midwest Foot & Ankle Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will remain blinded to the randomization assignment from the time of randomization assignment to the end of the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: June 9, 2021
• Study Start: May 5, 2021
• Primary Completion: July 31, 2022
• Study Completion: December 1, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)