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Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers

NCT01105884 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-03-04

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of different commonly used dressings for treating diabetic foot ulcers. It is a prospective study recruiting 50 type 2 diabetic patients with diabetic foot ulcers (2-50cm2). All the patients will give written informed consent prior to getting enrolled in the study. All the patients will be randomly assigned to one of the five groups of the study namely, saline (control),Biatin Ag (Foam), Hydrocolloid, Hydrogel and Ceredak. Follow up of the patients will be done until the complete healing of the wound takes place. All procedures of dressing will be done by an authorized and certified Podiatric Surgeon of the Institution. Details on the cost incurred and days required for the wound to completely heal will be recorded for all the patients.

This study will provide the efficacy of all the dressings used for treating diabetic foot ulcers and also the cost of each dressing. This will help the surgeons for managing the diabetic foot ulcers in a better and cost effective way, which in turn will reduce the burden of patients both physically and financially.

Conditions

  • Diabetic Foot Ulcers

Interventions

PROCEDURE

Normal Saline

All the subjects in Group 1 will be treated with Normal Saline for healing of their diabetic foot ulcer

PROCEDURE

Biatin Ag (Foam)

All the subjects will be treated with Biatin Ag (Foam)

PROCEDURE

Hydrocolloid

All the subjects in this group will be treated with Hydrocolloid

PROCEDURE

Hydrogel

All the subjects in this group will be treated with Hydrogel

PROCEDURE

Ceredak

All the subjects in this group will be treated with Micro-porous Ceramic Wound Dressing

Sponsors & Collaborators

  • M.V. Hospital for Diabetes

    lead OTHER

Principal Investigators

  • Vijay Viswanathan, Dr · DRC

  • Rajesh Kesavan, Dr. · DRC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • India

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 NCT01105884 on ClinicalTrials.gov