Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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:
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| 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.
|
Outcome Measures
Primary Outcome Measures
- 100% re-epithelialization [12 weeks]
Re-epithelialization will be assessed every week for 12 weeks or until 100% re-epithelialization, whichever occurs first.
Secondary Outcome Measures
- Decrease in Wound Area [12 weeks]
The difference in wound area from baseline to each time point will be summarized for each treatment group in each arm.
- Time to Wound Closure [12 weeks]
The number of weeks from initial application of study product until complete re-epithelialization is first identified.
- Number of Product Applications [12 weeks]
The number of study product applications including the initial application until 12 weeks or until complete re-epithelialization, whichever occurs first.
Other Outcome Measures
- Quality of Life - SF-36 [12 weeks]
The survey will be completed at the day of initial application and at either 12 weeks or at complete re-epithelialization
- Cost effectiveness / Economic model [12 weeks]
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.
- Incidence of adverse events [12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is at least 18 years old
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Patient is willing and capable of complying with all protocol requirements
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Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to or at the beginning of the run-in period
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Patient has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)
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Ulcer must be located at least in part on the foot or ankle
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Ulcer must be present for a minimum of 28 days prior to randomization and initial application of study product
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Wound size must be >1.0 cm2 and < 25 cm2 on the day of randomization and initial application of the study product, after initial debridement
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Patient has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
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Dorsum transcutaneous oxygen test (TcPO2) of study leg with results ≥40mmHg, OR
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Ankle-Brachial Index (ABI) of study leg with results of ≥ 0.7 and
≤ 1.3, OR
- Toe-Brachial Index (TBI) of study extremity with results of > 50 mmHg
Exclusion Criteria:
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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
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Patient is pregnant, breast feeding or planning to become pregnant
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Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
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Patient has a life expectancy less than six months as assessed by the investigator
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Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period
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Patient has an additional wound within 3 cm of the study wound
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Hgb A1c > 12% within 3 months prior to randomization in patients with a known history of diabetes
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Patient not in reasonable metabolic control in the judgment of the investigator
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Patient with a known history of poor compliance with medical treatments
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Patient currently undergoing cancer treatment
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Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
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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.
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Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgment of the investigator
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Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
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Patient unwilling to or unable to safely utilize appropriate offloading device to unweight wound
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Study ulcer experiences greater than 30% reduction over the 2-week run in period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Midwest Foot and Ankle Clinics | Hoffman Estates | Illinois | United States | 60169 |
Sponsors and Collaborators
- Acera Surgical, Inc.
Investigators
- Principal Investigator: Khalid Husain, DPM, Midwest Foot & Ankle Clinics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-RES-002