Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers

NCT05506215 | Terminated FDA Device

• 1 other identifier: CP-005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

Brief Summary

The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment. Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment

Conditions

Diabetic Foot; Chronic Foot Ulcer; Wound Healing; Foot Ulcer

Keywords

Ulcer; Diabetic; Acellular Dermal Matrix Template; Diabetes Complications

Outcome Measures

Primary Outcomes (1)

• Percentage of ulcer closed at 12 weeks

  Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart

  12 weeks

Secondary Outcomes (6)

• Percentage of ulcers that achieved 50% or greater closure rate within 6 weeks

  6 weeks

• Comparison of closure rates for each treatment group

  12 weeks

• Percent Wound Area Reduction(PWAR) over 12 weeks

  12 Weeks

• Cost of treatment in each treatment group

  12 weeks

• Change in reported Pain Levels between each treatment group

  12 weeks

Study Arms (2)

NovoSorb SynPath

EXPERIMENTAL

Arm receives application on NovoSorb SynPath Dermal Matrix and appropriate Off-loading

Device: SynPath Acellular Dermal Matrix plus Off-loading Device

Standard of Care

ACTIVE COMPARATOR

Arm receives application of wound dressing composed of 90% Collagen and 10% Alginate plus appropriate Off-loading

Device: Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device

Interventions

SynPath Acellular Dermal Matrix plus Off-loading Device DEVICE

Application of SynPath

NovoSorb SynPath

Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device DEVICE

Application Wound Dressing composed of Collagen and Alginate

Standard of Care

Eligibility Criteria

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

You may qualify if:

• Male or female ≥ 18 years
• A signed and dated informed consent form has been obtained from the subject
• Confirmed Type 1 or 2 diabetes with a hemoglobin HbA1c ≤12% within 90 days of informed consent
• Current reference ulcer has been in existence for longer than four (4) weeks with confirmed failure of a prior treatment to heal the ulcer, prior to signing informed consent for trial participation. Verbal statement from prior treating clinician or patient can be used as confirmation of treatment failure.
• Reference ulcer has been diagnosed as either a partial or full thickness diabetic foot ulcer without tunneling, undermining, sinus tracts or /exposed bone, with a scale rating of a Wagner Grade 1 or Wagner Grade 2 extended to ligament, tendon, and joint capsule with no bone exposure
• Ulcer is either located on the foot or ankle with at least 50% of ulcer below medial aspect of the malleolus
• Ulcer size (area) ≥1cm² and ≤25cm² post-debridement at both screening visit 1 and at baseline/randomization visit 3
• There is a minimum 1cm margin between the qualifying reference study ulcer and any other ulcers on the specified foot, post debridement
• Subject has adequate vascular perfusion of the affected limb, as defined by at least one of the following:
• Ankle-brachial Index (ABI) ≥ 0.65 or ≤1.2
• Toe pressure (plethysmography) \>50mmHg
• TcPO2 \>40mmHg
• Or as an alternative, the arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable.
• Subject or responsible caregiver is willing and able to adhere to schedule of required applicable dressing changes as well as off-loading for the location of the reference ulcer
• Subject is able and willing to comply with study procedures

You may not qualify if:

• Subject was previously randomized and treated under this clinical study protocol
• Subject has suspected or confirmed signs/symptoms of gangrene or wound infection as evidenced by redness, pain, and purulent drainage on any part of the index limb as confirmed by X-ray or biopsy
• Subject has a history of hypersensitivity to polyurethane, as determined by prior medical history
• Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 30 days of randomization
• Subject has received, or is scheduled to receive a medication or treatment which is known to interfere with or affect the rate or quality of wound healing within 30 days of signing the informed consent form
• Subject has a history of bone cancer or metastatic disease on the index limb, radiation therapy to the foot, or has had chemotherapy within twelve (12) months prior to signing informed consent form for trial participation
• Reference ulcer, in the clinical opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
• Subject has a condition that would interfere with their ability to adhere with the treatment regimen or has a known history of poor adherence with medical treatment
• In the opinion of the Investigator, the subject has a history of or is currently diagnosed with any illnesses or conditions, other than diabetes, that could interfere with wound healing such as auto-immune disorders, end-stage renal disease, severe malnutrition, liver disease or connective tissue disorders
• In the clinical opinion of the Investigator, the subject has an active or unstable Charcot foot
• Subject has ulcers secondary to a disease other than diabetes (e.g., vasculitis, neoplasms, or hematological disorders)
• In the clinical opinion of the Investigator, the subject has excessive lymphoedema that could interfere with off-loading and/or wound healing
• Subject with an active infection at the reference ulcer
• Subject has a non-healed surgical site from a prior amputation located in the index limb that has been open for less than 30 days
• Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes within 30 days of randomization or is scheduled to receive treatment during the study

Sponsors & Collaborators

• PolyNovo Biomaterials Pty Ltd.: lead

Study Sites (7)

Center for Clinical Research

Castro Valley, California, 94546, United States

Location

Limb Preservation Platform, Inc

Fresno, California, 93710, United States

Location

ILD Research Center

Vista, California, 92083, United States

Location

Barry University Clinical Research

Tamarac, Florida, 33321, United States

Location

Lower Extremity Institute for Research and Therapy, LLC

Youngstown, Ohio, 44512, United States

Location

JPS Health Network

Fort Worth, Texas, 76104, United States

Location

Foot and Ankle Specialists of Mid-Atlantic, LLC

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; Ulcer; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles M Zelen, DPM, FACFAC

  Profession Education and Research Institute, LLC

  STUDY DIRECTOR

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 16, 2022
• First Posted: August 18, 2022
• Study Start: July 10, 2022
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)