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Evaluation of a Folic Acid Wound Treatment (FAWT) for Chronic, Early-Stage Diabetic Foot Ulcer (DFU) Healing

NCT04723134 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-10-04

No results posted yet for this study

Summary

This is a twelve-week single-center, randomized, double-blind, clinical study to evaluate the safety and efficacy of a folic acid wound treatment (FAWT) versus Placebo in the promotion of healing of chronic, early stage diabetic foot ulcer (ES-DFU) wounds. Male and female Veterans with type-2 diabetes mellitus and chronic ES-DFUs acceptable to the study inclusion/exclusion criteria will be considered for enrollment.

Conditions

  • Diabetic Foot Ulcer

Interventions

COMBINATION_PRODUCT

Folinic acid calcium salt

Folinic acid (2.5%) by combination with Placebo

Sponsors & Collaborators

  • George Mason University

    collaborator OTHER

  • Central Arkansas Veterans Healthcare System

    collaborator FED

  • Joseph Boykin, MD

    lead FED

Principal Investigators

  • Joseph V Boykin, MD · Hunter Holmes McGuire VAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-09-24
Completion
2024-09-24
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 NCT04723134 on ClinicalTrials.gov