Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers

NCT06557122 | Completed Results FDA Device

• 1 other identifier: ENC-HEL-DFU-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute. In this trial two groups of subjects with Wagner 1 diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. Half of the patients will have their SOC treatment with Epifix® or Grafix® and the other half will receive a 510K FDA cleared Helicoll® Advanced Skin Substitute as the primary treatment. The primary endpoint is the percentage wound area reduction of the target ulcer. Secondary endpoints include the proportion of subjects that obtain complete closure over the 5-week treatment period, the time to achieve complete wound closure of the target ulcer by the end of 5 weeks, and mean number of IP applications.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Percentage of Wound Area Reduction

  Average Percentage of Wound Area Reduction from Treatment Visit 1 to Treatment Visit 4 measured manually with digital photography

  4 weeks

Secondary Outcomes (3)

• Number of Participants With Repeated Applications

  4 weeks

• Proportion of Complete Closure

  5 weeks

• Time to Achieve Complete Wound Closure

  5 weeks

Other Outcomes (1)

• Safety Analysis for Treatment Emergent Adverse Events

  5 weeks

Study Arms (2)

SOC and Advanced Bioengineered Skin Substitute

OTHER

The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).

Device: SOC and Advanced Bioengineered Skin Substitute

SOC and Active Comparator

OTHER

The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Dynaflex™ or equivalent).

Other: SOC and Active Comparator

Interventions

SOC and Advanced Bioengineered Skin Substitute DEVICE

SOC primary dressing with Helicoll®

SOC and Advanced Bioengineered Skin Substitute

SOC and Active Comparator OTHER

SOC primary dressing with Epifix® or Grafix®

SOC and Active Comparator

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 using a ruler to measure wound area.
• 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 of the target extremity.

You may not qualify if:

• The subject must consent to using the prescribed off-loading method for the duration of the study.
• The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
• The subject must be willing and able to participate in the informed consent process.
• Patients must have read and signed the IRB approved ICF before screening procedures are undertaken.
• A subject known to have a life expectancy of \< 6 months.
• If the target ulcer is infected or if there is cellulitis in the surrounding skin.
• Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
• A subject has an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
• Topical application of steroids to the ulcer surface within one month of initial screening.
• A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• A subject with a glycated hemoglobin (HbA1c) greater than or equal to 13% taken at or within 3 months of the initial screening visit.
• A subject with a serum creatinine ≥ 3.0mg/dL within 6 months of the initial screening visit.
• A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer.
• Women who are pregnant or considering becoming pregnant within the next 6 months.

Sponsors & Collaborators

• Encoll Corp: lead

Study Sites (3)

Clemente Clinical Research

Los Angeles, California, 90033, United States

Location

Doctors Research Network

South Miami, Florida, 33143, United States

Location

Foot and Ankle Specialists of the Mid-Atlantic

Salem, Virginia, 24153, United States

Location

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

Results Point of Contact

• Title: Dr. Subramanian Gunasekaran, PhD
• Organization: Encoll Corp

guna@encoll.com

+1 (510) 396-8581

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 12, 2024
• First Posted: August 16, 2024
• Study Start: July 25, 2024
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)