Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care

NCT06767501 | Recruiting FDA Device

• 1 other identifier: SKY-WP-DFU-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (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)
• Changes in neuropathy (nerve damage)
• Change in pain levels
• Occurrence of infection

Conditions

Diabetic Foot Ulcers (DFUs)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to healing within 12-weeks

  12-weeks

• Percentage Area Reduction over12 week period

  12-weeks

• Changes in peripheral neuropathy

  12-weeks

• Change in pain levels during trial

  12-weeks

Study Arms (2)

SOC primary dressing with E-GRAFT ™

EXPERIMENTAL

Participants receive standard of care with E-GRAFT™

Other: E-GRAFT ™

SOC primary dressing with FIBRACOL™

ACTIVE COMPARATOR

Participants receive standard of care with FIBRACOL™

Device: FIBRACOL™

Interventions

E-GRAFT ™ OTHER

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.

SOC primary dressing with E-GRAFT ™

FIBRACOL™ DEVICE

510K FDA cleared Collagen alginate dressing

SOC primary dressing with FIBRACOL™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be at least 18 years of age or older.
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
• At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement with manual measurement.
• 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.
• The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
• Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
• TCOM ≥30 mmHg
• ABI between 0.7 and 1.3
• PVR: Biphasic
• TBI ˃0.6
• As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle.

You may not qualify if:

• Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.
• The subject must consent to using the prescribed off-loading method for the duration of the study.
• The subject must agree to attend the weekly study visits required by the protocol.
• The subject must be willing and able to participate in the informed consent process.
• A subject known to have a life expectancy of \< 6 months is excluded.
• If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
• Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
• Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled
• A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
• A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• If a subject 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.
• If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.
• 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.
• A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.

Sponsors & Collaborators

• Skye Biologics Holdings, LLC: lead

Study Sites (1)

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Charles M Zelen, DPM FACFAS

  Professional Education and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Isaac, DPM

CONTACT

(301) 471-8378; aisaacdpm@gmail.com

Melissa Crosswhite

CONTACT

Mcrosswhite@periedu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 10, 2025
• Study Start: December 28, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)