Clinical Trial Evaluating a Hyaluronic Acid Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs)

NCT05198544 | Unknown

• 1 other identifier: LACERTA-001
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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 weeks followed by SOC alone for the remainder of the 12-week trial period. The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• Evaluate Wound healing in Wagner 1 and 2 grade DFUs by wound size

  To evaluate the effectiveness of HaM as an adjunctive treatment in facilitating complete wound healing in Wagner 1 and 2 grade DFUs when compared to well-established standard of care healing rates

  12 weeks

Secondary Outcomes (3)

• Evaluate Wound healing by wound closure

  12 weeks

• Evaluate wound healing by surface area reduction of greater than 40%

  4 weeks

• Occurrence of adverse events through case report forms

  12 weeks

Other Outcomes (1)

• Bacterial burden measured by Imaging

  12 weeks

Study Arms (1)

Hēlaquis Matrix is a hyaluronic acid matrix (HaM)

EXPERIMENTAL

Subjects will receive weekly application of Ham along with standard of care therapy for eight (8) weeks unless healing occurs prior to 8 weeks.

Device: Hēlaquis Matrix is a hyaluronic acid matrix (HaM)

Interventions

Hēlaquis Matrix is a hyaluronic acid matrix (HaM) DEVICE

Hēlaquis Matrix is a hyaluronic acid matrix (HaM) derived from the American Alligator and indicated for the treatment of chronic wounds. Hyaluronic Acid (HA) is a naturally occurring non sulphated glycosaminoglycan consisting of a linear sequence of D-glucuronic and N -acetyl-Dglucosamine. It is present in connective tissue and plays a role in several biological processes including tissue repair.

Hēlaquis Matrix is a hyaluronic acid matrix (HaM)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• Lacerta Life Sciences, LLC: collaborator

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

Central Study Contacts

Thomas Serena, MD, FACS

CONTACT

814-688-4000; serena@serenagroups.com

Sarah Moore, BSN, MBE

CONTACT

786-371-6184; smoore@serenagroups.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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 weeks followed by SOC alone for the remainder of the 12-week trial period. The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 20, 2022
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share