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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)

Primary Purpose

Diabetic Foot Ulcer, Venous Leg Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Synthetic Hybrid-Scale Fiber Matrix
Standard of Care
Living Cellular Skin Substitute
Sponsored by
Acera Surgical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ILD Research CenterRecruiting
  • University of Florida - Jacksonville
  • Barry University
  • Rush University Medical Center
  • Boston Medical CenterRecruiting
  • Methodist Physicians Clinic
  • University of North Carolina
  • Gundersen Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

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

Diabetic Foot Ulcer Participants Assigned to Standard of Care

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

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

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Decrease in Wound Area
Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements.
Time to 100 Percent Epithelialization
The number of weeks from initial application of study product until 100 percent epithelialization is first identified.
Number of Product Applications
The number of applications of study product until 100 percent epithelialization is first identified

Full Information

First Posted
June 3, 2021
Last Updated
October 20, 2023
Sponsor
Acera Surgical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04927702
Brief 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)
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acera Surgical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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®)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Venous Leg Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Arm Type
Experimental
Arm Description
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Arm Title
Diabetic Foot Ulcer Participants Assigned to Standard of Care
Arm Type
Active Comparator
Arm Description
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Arm Title
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Arm Type
Experimental
Arm Description
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Arm Title
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
Arm Type
Active Comparator
Arm Description
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Intervention Type
Device
Intervention Name(s)
Synthetic Hybrid-Scale Fiber Matrix
Other Intervention Name(s)
Restrata
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard of Care
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Living Cellular Skin Substitute
Other Intervention Name(s)
Apligraf
Intervention Description
An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
Primary Outcome Measure Information:
Title
For Participants With Diabetic Foot Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound
Description
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
Time Frame
12 weeks
Title
For Participants With Venous Leg Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound
Description
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
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Decrease in Wound Area
Description
Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements.
Time Frame
Weekly assessments for 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.
Title
Time to 100 Percent Epithelialization
Description
The number of weeks from initial application of study product until 100 percent epithelialization is first identified.
Time Frame
12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.
Title
Number of Product Applications
Description
The number of applications of study product until 100 percent epithelialization is first identified
Time Frame
12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
Other Pre-specified Outcome Measures:
Title
Score on SF-36 Questionnaire Measuring Quality of Life
Time Frame
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)
Title
Pain Reported By Participant
Description
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
Time Frame
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)
Title
Number of Adverse Events Related to the Study Product and/or Procedure
Time Frame
Up to six months
Title
Investigator's Rating of the Ease of Use and Handling of Study Product
Description
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"
Time Frame
12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
Title
Cost Effectiveness
Description
Total cost of study product applied to the participant
Time Frame
12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
Title
Number of participants with coverage of product by payor (insurance)
Time Frame
12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Participants with Diabetic Foot Ulcers: Participant is at least 18 years old Participant is willing and capable of complying with all protocol requirements Participant or legally authorized representative (LAR) is willing to provide written informed consent Participant has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association) Ulcer(s) must be located at least in part on the foot or ankle 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 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 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: Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) with results ≥40mmHg, OR Ankle-Brachial Index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.3, OR Toe-Brachial Index (TBI) of study extremity(ies) with results of ≥ 0.5 Exclusion Criteria for Participants with Diabetic Foot Ulcers: 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 Participant is pregnant, breast feeding or planning to become pregnant Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS) Participant has a life expectancy less than six months as assessed by the investigator Participant has received skin substitutes during the screening period or within 14 days prior to beginning of screening period Participant has an additional wound within 3 cm of the study wound(s) or study wounds are less than 3 cm apart Hgb A1c > 12 percent within 3 months prior to randomization Participant not in reasonable metabolic control in the judgment of the investigator Participant with a known history of poor compliance with medical treatments Participant currently undergoing cancer treatment Participant has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis 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. Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence Participant unwilling or unable to safely utilize appropriate offloading device to unweight wound(s) Study ulcer(s) experiences greater than 30 percent reduction over the 2-week screening period Participant also has a venous leg ulcer that is enrolled into this study Inclusion Criteria for Participants with Venous Leg Ulcers: Participant is at least 18 years old Participant is willing and capable of complying with all protocol requirements Participant or legally authorized representative (LAR) is willing to provide written informed consent Participant has peripheral venous disease per investigator judgment or diagnostic confirmation Ulcer(s) must be venous in origin, located on a lower extremity 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 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 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: Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) with results ≥ 40mmHg, OR Ankle-brachial index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.52, OR Toe-Brachial Index (TBI) of study leg(s) with results of ≥ 0.5, OR Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected leg(s) Exclusion Criteria for Participants with Venous Leg Ulcers: 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 Participant is pregnant, breast feeding or planning to become pregnant Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS) Participant has a known allergy to bovine materials or agarose shipping materials Participant has a life expectancy less than six months as assessed by the investigator Participant has received skin substitutes during the screening period or within 14 days prior to the beginning of the screening period Participant has an additional wound within 3 cm of the study wound or study wounds are less than 3 cm apart Hgb A1c > 12 percent within 3 months prior to randomization in patients with a known history of diabetes Participant is not in reasonable metabolic control in the judgment of the investigator Participant has a known history of poor compliance with medical treatments Participant currently undergoing cancer treatment Participant has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis 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. Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator Participant unwilling or unable to tolerate use of compression therapy for the duration of the study Study ulcer(s) experiences greater than 30 percent reduction over the 2-week run-in period Participant also has a diabetic foot ulcer that is enrolled into this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chief Science Officer
Phone
844-879-2237
Email
macewan@acera-surgical.com
Facility Information:
Facility Name
ILD Research Center
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Martinez
Phone
760-350-5080
Ext
6
Email
eric@ildresearch.com
First Name & Middle Initial & Last Name & Degree
Yani Manzanares
Email
yani@ildresearch.com
First Name & Middle Initial & Last Name & Degree
Dean Vayser, DPM
Facility Name
University of Florida - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Terminated
Facility Name
Barry University
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Individual Site Status
Terminated
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nolan Joyce, MPH
Email
Nolan.Joyce@bmc.org
First Name & Middle Initial & Last Name & Degree
Vitaliy Volansky, DPM
Facility Name
Methodist Physicians Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Withdrawn
Facility Name
Gundersen Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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