Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Diabetic Foot Ulcers

In brief

A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT ULCERS (cDFU)

Key facts

Study ID

NCT05276401

Run by

Lakewood-Amedex Inc

People needed

3

Starts

2022-03-11

Expected to finish

2022-06-15

Last updated by the study team

2024-01-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women at least 18 years of age and up to 80 years of age, inclusive.
• Voluntary written consent, given before performance of any clinical investigation-related procedure, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
• Non-hospitalized ambulatory subjects suffering from diabetes mellitus, Type I or II per ADA criteria.
• The target ulcer is classified as grade 1 ulcer according to a Wagner Scale. These ulcers are superficial, full-thickness ulcers limited to the dermis, not extending to the subcutis.
• Target ulcer is between 2 and 10 cm2 post debridement at screening and baseline.
• The target ulcer must be no higher than the ankle (on or below the malleolus (ankle bone) with ≥50% below the malleolus.
• Presence of a persistent cDFU for at least 4 weeks and not more than 1 year that has failed to respond to standard of care.
• Adequate vascular perfusion as evidenced by one of the following:
• Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg.
• Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of Screening using the extremity with the target ulcer.
• Arterial Doppler ultrasound evaluating for biphasic or triphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of > 0.6 is acceptable.
• Subject has a caregiver who is able to attend baseline visit and apply wound treatment and study dressings for the study duration.
• Subject completed protocol-defined standardized wound care during the Screening and Run-in periods leading up to Day 0.
• Must meet one of the following criteria:
• a. Female subjects of Non-Child-Bearing Potential defined as: i. Postmenopausal for at least 1 year, or surgically sterilized (i.e., hysterectomy or bilateral oophorectomy more than 3 months prior to Screening), or ii. Bilateral tubal ligation more than 6 months prior to Screening iii. Must have a negative serum β-hCG pregnancy test at screening and not be breastfeeding prior to being administered with the study drug.
• b. Male subjects of Non-Childbearing Potential defined as those vasectomized subjects whose vasectomy was performed 6 months prior to Screening or those diagnosed as sterile by a physician.
• c. Females and Males of Childbearing Potential who practice an acceptable method of contraception defined as the use of any form of hormonal contraceptive, a barrier method with spermicide, condoms, intrauterine device, or abstinence from sexual intercourse starting at least 60 days prior to Screening and continuing at least 30 days following the last treatment.
• Subjects must be willing to undergo all clinical investigation-related procedures and attend all required visits.

You may not qualify if…

• Ulceration with exposed tendon, capsule, or bone.
• Suspicion of bone or joint infection by clinical or other criteria.
• Unable or unwilling to utilize the standardized offloading RCW as required per protocol.
• Target ulcer has decreased in area by ≥30% between Screening (V1) and Baseline (V3) visits.
• Any subject that is currently on/requires oral, systemic or topical antibiotics, or is anticipated to require use during the course of the trial.
• Any subject that has vascular compromise requiring surgical intervention or has undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Any planned surgical procedures during the study participation.
• Serum Creatinine level >3.0 mg/dL.
• Hemoglobin A1c (HbA1c) >12%.
• Aspartate Aminotransferase (AST, GOT) and/or Alanine Aminotransferase (ALT, GPT) >3x the upper limit of normal.
• Acute active Charcot foot.
• The target ulcer is within 3 cm of any other ulcer.
• Any subject that would be unable to safely monitor the infection status at home, and return for scheduled visits.
• History of immunosuppression or taking immunosuppressive agents including systemic corticosteroids, except stable daily doses of 5 mg/day or less for chronic conditions.
• Any subject with a life expectancy ≤ 6 months.
• Pregnancy, including a positive pregnancy test at Screening or Baseline, or lactation.
• Use of investigational drugs within 28 days prior to screening.
• History of concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.
• Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel.
• Known or suspected active abuse of alcohol, narcotics, or non-prescription drugs.
• Prior randomization in this clinical trial, or a previous Bisphosphocin study.

Where it is running

• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Limb Preservation Platform, Inc. — Fresno, California, United States
• Doctors Research Network — South Miami, Florida, United States
• ACM Global Laboratories — Rochester, New York, United States
• Futuro Clinical Trials, LLC — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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