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)

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 Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04927702
• Other study ID #: 21-RES-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2024
• Source: Acera Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Synthetic Hybrid-Scale Fiber Matrix
A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
• Standard of Care
To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
• Living Cellular Skin Substitute
An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Florida - Jacksonville	Jacksonville	Florida
United States	Gundersen Health System	La Crosse	Wisconsin
United States	Barry University	Miami Beach	Florida
United States	ILD Research Center	Vista	California

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	Score on SF-36 Questionnaire Measuring Quality of Life		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)
Other	Pain Reported By Participant	The pain reported by the participant on a scale of 0 through 10 with 10 being the highest level of pain the participant has experienced	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)
Other	Number of Adverse Events Related to the Study Product and/or Procedure		Up to six months
Other	Investigator's Rating of the Ease of Use and Handling of Study Product	Investigator's rating of the ease of use and handling of the study product. Investigator will rate study product as "very satisfied", "satisfied", or "not satisfied"	12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
Other	Cost Effectiveness	Total cost of study product applied to the participant	12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
Other	Number of participants with coverage of product by payor (insurance)		12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
Primary	For Participants With Diabetic Foot Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound	100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization	12 weeks
Primary	For Participants With Venous Leg Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound	100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization	16 weeks
Secondary	Decrease in Wound Area	Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements.	Weekly assessments for 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.
Secondary	Time to 100 Percent Epithelialization	The number of weeks from initial application of study product until 100 percent epithelialization is first identified.	12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.
Secondary	Number of Product Applications	The number of applications of study product until 100 percent epithelialization is first identified	12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first