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The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer

NCT05850611 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-10-04

No results posted yet for this study

Summary

The aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of platelet-rich plasma-fibrin glue as an effective treatment for wound healing.

Conditions

  • Diabetic Foot Ulcers
  • Diabetic Wound

Interventions

DRUG

Methylene Blue

The first intervention group includes diabetic patients with chronic foot ulcers who, despite common treatments, will be undergone oral methylene blue intervention for 4 weeks.

OTHER

Milk (control)

Group B will receive 200 ml of milk for 4 weeks.

DRUG

Methylene Blue and Platelet-Rich Plasma-Fibrin Glue

Group C will be undergone synergistic 4-week treatment with oral methylene blue and fibrin glue.

OTHER

Milk and Platelet-Rich Plasma-Fibrin Glue (control)

Group D will be treated only with fibrin glue and 200 ml of milk for 4 weeks.

Sponsors & Collaborators

  • Mashhad University of Medical Sciences

    lead OTHER

Principal Investigators

  • Daryoush Hamidi Alamdari, Ph.D · Mashhad University of Medical Sciences, Mashhad, Iran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2023-08-21
Completion
2024-09-21

Countries

  • Iran

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 NCT05850611 on ClinicalTrials.gov