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

February 16, 2022 updated by: Vijay Viswanathan, M.V. Hospital for Diabetes

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This prospective study aims at determining the efficacy and safety of different dressings available for treating diabetic foot ulcers. Study has been approved by the Institutional Ethics Committee before starting. Informed consent will be obtained from all the study subjects. A total of 50 subjects will be recruited. Study subjects will be divided in five groups of 10 subjects in each group.All the subjects will be randomly assigned to one of the study groups namely; Group 1 will the subjects randomized on Normal Saline (Control) and group 2 will be the subjects randomized on Biatin Ag (Foam) dressing; Group 3 will be Hydrocolloid, group 4 will be Hydrogel and Group 5 will be Ceredak. Lab investigations involving glycemic status (HbA1c), lipid profile, renal function test, liver function test will be done using standard enzymatic procedures. Wound size, colony count and microflora of the wound will be captured for all the study subjects. Photographs of the wound will be taken at every follow up visit until the wound is healed. Serum and tissue sample will be collected for the estimation of pronounced markers like MMP 2 and MMP 9. MMP 2 will be estimated using ELISA procedure (using standard enzymatic assay kit) and MMP 9 will be estimated using western blot technique. Histopathology of collagen will be seen using Van Gieson's stain. Immunohistochemistry will be done for determining collagen IV (marker for basement membrane thickening) to prove the evident wound healing at a defined point of time. H&E sections will be taken for determining the inflammation histochemically. All the study subjects will be followed till the wound healing process is complete. Tissue and serum samples will be collected for the above mentioned parameters on pre application day, after 1st and 4th week of the dressing application. A total of 3 visits will be performed for all the study subjects.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600013
        • Diabetes Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with foot ulcers
  • Patients with or without PVD
  • Size of the ulcer: 2-50 cm2
  • Age 30-75 years (both gender)

Exclusion Criteria:

  • Patient having severe infection
  • Size of the foot ulcer > 50cm2
  • Patients not willing to give written informed consent
  • Patient with psychological disorder
  • Patients with severe renal impairment or visual deformity
  • Patients above the age of 75 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Procedure: Normal Saline
All the subjects in Group 1 will be treated with Normal Saline for healing of their diabetic foot ulcer
Active Comparator: Group 2
Procedure: Biatin Ag (Foam)
All the subjects will be treated with Biatin Ag (Foam)
Other Names:
  • Coloplast
Active Comparator: Group 3
Procedure: Hydrocolloid
All the subjects in this group will be treated with Hydrocolloid
Other Names:
  • Coloplast
Active Comparator: Group 4
Procedure: Hydrogel
All the subjects in this group will be treated with Hydrogel
Other Names:
  • Coloplast - Purilon Gel
Active Comparator: Group 5
Procedure: Ceredak
All the subjects in this group will be treated with Micro-porous Ceramic Wound Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete healing of the wound
Time Frame: 1 months from the date of application
1 months from the date of application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.V. Hospital for Diabetes

Investigators

  • Principal Investigator: Vijay Viswanathan, Dr, DRC
  • Study Director: Rajesh Kesavan, Dr., DRC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

April 16, 2010

First Submitted That Met QC Criteria

April 16, 2010

First Posted (Estimate)

April 19, 2010

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Foot Ulcers

Clinical Trials on Normal Saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe