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

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ClinicalTrials.gov Identifier: NCT04927702
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Acera Surgical, Inc.

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 lyophilized acellular fish skin (Kerecis® Omega3 Wound).

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®)


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Venous Leg Ulcer Device: Synthetic Hybrid-Scale Fiber Matrix Device: Lyophilized Acellular Fish Skin Device: Living Cellular Skin Substitute Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Lyophilized Acellular Fish Skin in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
Actual Study Start Date : July 19, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : July 1, 2023


Arm Intervention/treatment
Experimental: Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
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.
Other Name: Restrata

Active Comparator: Diabetic Foot Ulcer Participants Assigned to Lyophilized Acellular Fish Skin (Kerecis® Omega3 Wound)
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Device: Lyophilized Acellular Fish Skin
An absorbable skin substitute comprised of intact North Atlantic Cod fish skin indicated for use in the local management of wounds.
Other Name: Kerecis Omega3 Wound

Experimental: Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
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.
Other Name: Restrata

Active Comparator: Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Device: Living Cellular Skin Substitute
An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
Other Name: Apligraf




Primary Outcome Measures :
  1. For Participants With Diabetic Foot Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound [ Time Frame: 12 weeks ]
    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

  2. For Participants With Venous Leg Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound [ Time Frame: 16 weeks ]
    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 :
  1. Decrease in Wound Area [ Time Frame: Weekly assessments for 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first. ]
    Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements.

  2. Time to 100 Percent Epithelialization [ Time Frame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first. ]
    The number of weeks from initial application of study product until 100 percent epithelialization is first identified.

  3. Number of Product Applications [ Time Frame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first ]
    The number of applications of study product until 100 percent epithelialization is first identified


Other Outcome Measures:
  1. 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) ]
  2. Pain Reported By Participant [ 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) ]
    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

  3. Number of Adverse Events Related to the Study Product and/or Procedure [ Time Frame: Up to six months ]
  4. Investigator's Rating of the Ease of Use and Handling of Study Product [ Time Frame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first ]
    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"

  5. Cost Effectiveness [ Time Frame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first ]
    Total cost of study product applied to the participant

  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 known allergy to fish or fish material
  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 beginning of screening period
  7. Participant has an additional wound within 3 cm of the study wound(s) or study wounds are less than 3 cm apart
  8. Hgb A1c > 12 percent within 3 months prior to randomization
  9. Participant not in reasonable metabolic control in the judgment of the investigator
  10. Participant with 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. Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
  16. Participant unwilling or unable to safely utilize appropriate offloading device to unweight wound(s)
  17. Study ulcer(s) experiences greater than 30 percent reduction over the 2-week screening period
  18. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04927702


Contacts
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Contact: Chief Science Officer 844-879-2237 macewan@acera-surgical.com

Locations
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United States, Colorado
University of Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Michael Hewitt, DPM    303-724-4298    michael.a.hewitt@cuanschutz.edu   
Principal Investigator: Garrett Moore, DPM         
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Matthew Johnson    312-942-1735    matthew_johnson@rush.edu   
Principal Investigator: Thea P Price, MD         
United States, Nebraska
Methodist Physicians Clinic Recruiting
Omaha, Nebraska, United States, 68114
Contact: DruAnne McMartin    402-354-0350    dru.mcmartin@nmhs.org   
Principal Investigator: John M Park, MD         
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Zachary Gortler    919-843-1268    zachary_gortler@med.unc.edu   
Principal Investigator: William Marston, MD         
United States, Wisconsin
Gundersen Health System Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Kim Halverson    608-775-0852    kehalver@gundersenhealth.org   
Principal Investigator: Bradley P Abicht, DPM         
Sponsors and Collaborators
Acera Surgical, Inc.
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Responsible Party: Acera Surgical, Inc.
ClinicalTrials.gov Identifier: NCT04927702    
Other Study ID Numbers: 21-RES-001
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetic Foot
Varicose Ulcer
Foot Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Varicose Veins