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

Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcer

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Restrata®; Device: Wound Dressing

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Midwest Foot and Ankle Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: Synthetic Hybrid-Scale Fiber Matrix
Active Comparator: 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.	Device: Wound Dressing; Alginate or Foam wound dressing is intended to manage wounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Wound Area	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.	12 weeks
Number of Treatment Applications	The number of study treatment applications including the initial application until 12 weeks or until complete re-epithelialization, whichever occurs first.	12 weeks
Time to Wound Closure	The number of weeks from initial application of study treatment until complete re-epithelialization is first identified.	Up to 12 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life - SF-36	The survey will be completed at the day of initial application and at either 12 weeks or at complete re-epithelialization	12 weeks
Incidence of Adverse Events		12 weeks
Cost Effectiveness / Economic Model	Cost data from the patient's treatment will be analyzed based on diagnoses, procedure and supply codes to determine cost efficacy and outcomes with the treatment pathway and related technology utilized during the course of care.	12 weeks

Collaborators and Investigators

• Sponsor: Acera Surgical, Inc.
• Investigators: Principal Investigator: Khalid Husain, DPM, Midwest Foot & Ankle Clinics

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcer; Epithelialization; Synthetic Hybrid-Scale Fiber Matrix
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 21-RES-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No