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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01105884
Other study ID # CDS01
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2009
Est. completion date July 2012

Study information

Verified date February 2022
Source M.V. Hospital for Diabetes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Normal Saline
All the subjects in Group 1 will be treated with Normal Saline for healing of their diabetic foot ulcer
Biatin Ag (Foam)
All the subjects will be treated with Biatin Ag (Foam)
Hydrocolloid
All the subjects in this group will be treated with Hydrocolloid
Hydrogel
All the subjects in this group will be treated with Hydrogel
Ceredak
All the subjects in this group will be treated with Micro-porous Ceramic Wound Dressing

Locations

Country Name City State
India Diabetes Research Centre Chennai Tamil Nadu

Sponsors (1)

Lead Sponsor Collaborator
M.V. Hospital for Diabetes

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary complete healing of the wound 1 months from the date of application
See also
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