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Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer

NCT05276401 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-01-30

Study results available
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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)

Conditions

  • Chronic Diabetic Foot Ulcers

Interventions

DRUG

5% Bisphosphocin Topical Gel

Topical Gel

DRUG

Placebo Topical Gel

Topical Gel

DRUG

10% Bisphosphocin Topical Gel

Topical Gel

Sponsors & Collaborators

  • Professional Education and Research Institute

    collaborator OTHER

  • PrimeVigilance

    collaborator INDUSTRY

  • Lakewood-Amedex Inc

    lead INDUSTRY

Principal Investigators

  • Sumita Paul, MD, MPH · Lakewood-Amedex Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2022-05-18
Completion
2022-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05276401 on ClinicalTrials.gov