Status:
UNKNOWN
Clinical Trial Evaluating a Hyaluronic Acid Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs)
Lead Sponsor:
SerenaGroup, Inc.
Collaborating Sponsors:
Lacerta Life Sciences, LLC
Conditions:
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs. After screening, subjects are treated with weekly application of HaM and SOC for 8 we...
Detailed Description
This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs. After screening, subjects are treated with weekly application of HaM and SOC for 8 we...
Eligibility Criteria
Inclusion
- At least 18 years old.
- Presence of a diabetic foot ulcer, Wagner 1 or 2 grade, extending at least through the dermis. The ulcer may extend down to subcutaneous tissue, tendon, or muscle.
- The ulcer must be below the medial aspect of the malleoli.
- The index ulcer will be the largest ulcer if 2 or more ulcers are present on the same extremity. If other ulcerations are present on the same foot, they must be more than 2 cm from the index ulcer.
- Index ulcer (i.e., current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit.
- Study ulcer size is a minimum of 0.75 cm2 and a maximum of 5 cm2 at first treatment visit.
- Adequate circulation to the affected extremity as demonstrated by a transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg, OR an Ankle Brachial Index (ABI - measure of blood flow to the ankle) between 0.7 and 1.3 OR Toe Brachial Index greater than 0.5 within 3 months of the first Screening Visit.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- Subject has read and signed the IRB approved Informed Consent Form before screening procedures are undertaken.
Exclusion
- Study ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- History of radiation at the ulcer site.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
- Known Osteomyelitis or bone infection of the affected foot or leg as verified by diagnostic imaging within 30 days prior to enrollment.
- Subject is pregnant or breast feeding.
- Study ulcer with a history of treatment with hyperbaric oxygen or a cellular or Tissue-based Product (CTP) within 30 days of enrollment.
- Subject has a known or suspected allergy to the test material.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05198544
Start Date
June 1 2023
End Date
December 31 2023
Last Update
April 26 2023
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