Status:
TERMINATED
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
Lead Sponsor:
Lakewood-Amedex Inc
Collaborating Sponsors:
Professional Education and Research Institute
PrimeVigilance
Conditions:
Chronic Diabetic Foot Ulcers
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 NONINFECT...
Detailed Description
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and tolerability of twice daily (BID) topically administered concentrations...
Eligibility Criteria
Inclusion
- 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before performance of any clinical investigation-related procedure, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05276401
Start Date
March 11 2022
End Date
June 15 2022
Last Update
January 30 2024
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72405
2
Limb Preservation Platform, Inc.
Fresno, California, United States, 93710
3
Doctors Research Network
South Miami, Florida, United States, 33143
4
ACM Global Laboratories
Rochester, New York, United States, 14624