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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918784
• Other study ID #: 21-RES-002
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2023
• Source: Acera Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 1, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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.
• Wound Dressing
Alginate or Foam wound dressing is intended to manage wounds.

Locations

Country	Name	City	State
United States	Midwest Foot and Ankle Clinics	Hoffman Estates	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Acera Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Incidence of Adverse Events		12 weeks
Primary	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	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
Secondary	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
Secondary	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