Clinical trial NCT04927702: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcer
Venous Leg Ulcer
Lead sponsor: Acera Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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®)


Eligibility 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

Primary outcomes:
measure: For Participants With Diabetic Foot Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound
timeFrame: 12 weeks
measure: For Participants With Venous Leg Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound
timeFrame: 16 weeks
Secondary outcomes:
measure: Decrease in Wound Area
timeFrame: Weekly assessments for 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.
measure: Time to 100 Percent Epithelialization
timeFrame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.
measure: Number of Product Applications
timeFrame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
Other outcomes:
measure: Score on SF-36 Questionnaire Measuring Quality of Life
timeFrame: Day of initial product application and at either 12 weeks for DFU participants (16 weeks for VLU participants) or at 100 percent epithelialization (whichever occurs first)
measure: Pain Reported By Participant
timeFrame: Day of initial product application and at either 12 weeks for DFU participants (16 weeks for VLU participants) or at 100 percent epithelialization (whichever occurs first)
measure: Number of Adverse Events Related to the Study Product and/or Procedure
timeFrame: Up to six months
measure: Investigator's Rating of the Ease of Use and Handling of Study Product
timeFrame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
measure: Cost Effectiveness
timeFrame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
measure: Number of participants with coverage of product by payor (insurance)
timeFrame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
Locations:
city: Vista
country: United States
facility: ILD Research Center
state: California
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville
state: Florida
city: Miami Beach
country: United States
facility: Barry University
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
Study officials:
References: