Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)

Acera Surgical

Status: Terminated

Conditions: Venous Leg Ulcer; Diabetic Foot Ulcer

Treatments: Device: Standard of Care; Device: Synthetic Hybrid-Scale Fiber Matrix; Device: Living Cellular Skin Substitute

Study type: Interventional

Funder types: Industry

Identifiers

NCT04927702

21-RES-001

Details and patient eligibility

About

In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.

In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Participants with Diabetic Foot Ulcers:

1. Participant is at least 18 years old

2. Participant is willing and capable of complying with all protocol requirements

3. Participant or legally authorized representative (LAR) is willing to provide written informed consent

4. Participant has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)

5. Ulcer(s) must be located at least in part on the foot or ankle

6. Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy

7. Wound size must be >1.0 cm^2 and < 25 cm^2 on the day of randomization and initial application of the study product, after initial debridement

8. Participant has adequate circulation to the affected extremity(ies), 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(s) with results ≥40mmHg, OR
   2. Ankle-Brachial Index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.3, OR
   3. Toe-Brachial Index (TBI) of study extremity(ies) with results of ≥ 0.5

Exclusion Criteria for Participants with Diabetic Foot Ulcers:

1. Participant has been previously enrolled into this study, or is currently participating in another prospective drug or device study that has not reached its primary endpoint
2. Participant is pregnant, breast feeding or planning to become pregnant
3. Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
4. Participant has a life expectancy less than six months as assessed by the investigator
5. Participant has received skin substitutes during the screening period or within 14 days prior to beginning of screening period
6. Participant has an additional wound within 3 cm of the study wound(s) or study wounds are less than 3 cm apart
7. Hgb A1c > 12 percent within 3 months prior to randomization
8. Participant not in reasonable metabolic control in the judgment of the investigator
9. Participant with a known history of poor compliance with medical treatments
10. Participant currently undergoing cancer treatment
11. Participant has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
12. Participant is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the screening period or up to 30 days before the screening 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(s) 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. Participant unwilling or unable to safely utilize appropriate offloading device to unweight wound(s)
16. Study ulcer(s) experiences greater than 30 percent reduction over the 2-week screening period
17. Participant also has a venous leg ulcer that is enrolled into this study

Inclusion Criteria for Participants with Venous Leg Ulcers:

1. Participant is at least 18 years old

2. Participant is willing and capable of complying with all protocol requirements

3. Participant or legally authorized representative (LAR) is willing to provide written informed consent

4. Participant has peripheral venous disease per investigator judgment or diagnostic confirmation

5. Ulcer(s) must be venous in origin, located on a lower extremity

6. Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy

7. Wound(s) size must be >1.0 cm^2 and < 50 cm^2 on the day of randomization and initial application of the study product, after initial debridement

8. Participant has adequate circulation to the affected extremity(ies), 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(s) with results ≥ 40mmHg, OR
   2. Ankle-brachial index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.52, OR
   3. Toe-Brachial Index (TBI) of study leg(s) with results of ≥ 0.5, OR
   4. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected leg(s)

Exclusion Criteria for Participants with Venous Leg Ulcers:

1. Participant has been previously enrolled into this study, or is currently participating in another prospective drug or device study that has not reached its primary endpoint
2. Participant is pregnant, breast feeding or planning to become pregnant
3. Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
4. Participant has a known allergy to bovine materials or agarose shipping materials
5. Participant has a life expectancy less than six months as assessed by the investigator
6. Participant has received skin substitutes during the screening period or within 14 days prior to the beginning of the screening period
7. Participant has an additional wound within 3 cm of the study wound or study wounds are less than 3 cm apart
8. Hgb A1c > 12 percent within 3 months prior to randomization in patients with a known history of diabetes
9. Participant is not in reasonable metabolic control in the judgment of the investigator
10. Participant has a known history of poor compliance with medical treatments
11. Participant currently undergoing cancer treatment
12. Participant has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
13. Participant is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the screening period or up to 30 days before the screening period. Chronic oral steroid use is not excluded if dose is < 10 mg per day for prednisone.
14. Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator
15. Participant unwilling or unable to tolerate use of compression therapy for the duration of the study
16. Study ulcer(s) experiences greater than 30 percent reduction over the 2-week run-in period
17. Participant also has a diabetic foot ulcer that is enrolled into this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 4 patient groups

Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)

Experimental group

Description:

Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Treatment:

Device: Synthetic Hybrid-Scale Fiber Matrix

Diabetic Foot Ulcer Participants Assigned to Standard of Care

Active Comparator group

Description:

Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Treatment:

Device: Standard of Care

Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)

Experimental group

Description:

Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Treatment:

Device: Synthetic Hybrid-Scale Fiber Matrix

Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)

Active Comparator group

Description:

Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Treatment:

Device: Living Cellular Skin Substitute