Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer (NCT05276401) | Clinical Trial Compass
TerminatedPhase 2
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
Stopped: Request for additional preclinical data.
United States3 participantsStarted 2022-03-11
Plain-language 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 NONINFECTED CHRONIC DIABETIC FOOT ULCERS (cDFU)
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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before performance of any clinical investigation-related procedure, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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:
Exclusion criteria
✕. 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.
What they're measuring
1
To Assess the Number of Participants With Treatment-related Adverse Events After Nu-3 Gel Use on cDFU as Assessed by CTCAE v4.0
. 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.