Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone

A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone

The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with SOC versus FIBRACOL™ with SOC. Other research purposes include the following:

• Rate of wound closure
• Change in ulcer size over 12 weeks
• Any adverse events or reactions (side effects)
• Change in pain levels
• Occurrence of infection

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcers
• Intervention / Treatment: Other: E-GRAFT ™; Device: FIBRACOL™

Detailed Description

The purpose of this clinical evaluation is to collect patient outcome data on a commercially available E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue- Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act. In this trial, two groups of Venous Leg Ulcers (VLUs) will receive standard of care (SOC) treatment for their condition. Half of the patients will receive a 510K FDA cleared Collagen alginate dressing FIBRACOL™ and the other half will have E-GRAFT™ dehydrated tissue allograft as the primary dressing. The primary endpoint is the percentage of patients that go on to complete closure of the target ulcer between the two groups: SOC with FIBRACOL™ or SOC with E-GRAFT™. Secondary endpoints include the proportion of subjects achieving complete wound closure of the target ulcer by the end of 12 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Isaac, DPM; Phone Number: (301) 471-8378; Email: aisaacdpm@gmail.com
• Study Contact Backup: Name: Melissa Crosswhite; Email: Mcrosswhite@periedu.com

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Recruiting
      • Professional Education and Research Institute
      • Contact: Charles M Zelen, DPM FACFAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must be at least 18 years of age or older.
2. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with manual measure.
3. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
4. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
5. The subject must consent to using the prescribed off-loading method for the duration of the study.
6. The subject must agree to attend the weekly study visits required by the protocol.
7. The subject must be willing and able to participate in the informed consent process.
8. The target ulcer must be full thickness on the foot or leg that does not probe to bone.

9. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:

   1. TCOM ≥30 mmHg
   2. ABI between 0.7 and 1.3
   3. PVR: Biphasic
   4. TBI ˃0.6
   5. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle
10. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
11. Target ulcers must have been treated with compression therapy for at least 14 days prior to randomization.

Exclusion Criteria:

1. A subject known to have a life expectancy of < 6 months is excluded.
2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
4. Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled
5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
7. A subject with a previous partial amputation on the affected leg is excluded if the resulting deformity impedes proper offloading of the target ulcer.
8. If a subject is diabetic and has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.
9. If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
10. The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.
11. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
12. A potential subject with end stage renal disease requiring dialysis is excluded.
13. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
14. A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOC primary dressing with E-GRAFT ™; Participants receive standard of care with E-GRAFT™	Other: E-GRAFT ™; E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue-Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act.
Active Comparator: SOC primary dressing with FIBRACOL™; Participants receive standard of care with FIBRACOL™	Device: FIBRACOL™; 510K FDA cleared Collagen alginate dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the proportion of index ulcers "healed" at 12 weeks	Investigator assessment of healing (100% epithelization w/no drainage), measurements of ulcer size using manual measurements	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to healing within 12 weeks	Time to healing will be taken as the time of first assessment (i.e. before confirmation within two weeks) of complete healing.	12 weeks
Percentage Area Reduction over 12 week period	Digital imaging	12 weeks

Collaborators and Investigators

• Sponsor: Skye Biologics Holdings, LLC
• Investigators: Principal Investigator: Charles M Zelen, DPM FACFAS, Professional Education and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer; Leg Ulcer
• Other Study ID Numbers: SKY-WP-VLU-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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