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

Sponsors

Lead Sponsor: M.V. Hospital for Diabetes

Source M.V. Hospital for Diabetes
Brief 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.

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.

Overall Status Unknown status
Start Date October 2009
Completion Date July 2012
Primary Completion Date July 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
complete healing of the wound 1 months from the date of application
Enrollment 50
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Normal Saline

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

Arm Group Label: Group 1

Intervention Type: Procedure

Intervention Name: Biatin Ag (Foam)

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

Arm Group Label: Group 2

Other Name: Coloplast

Intervention Type: Procedure

Intervention Name: Hydrocolloid

Description: All the subjects in this group will be treated with Hydrocolloid

Arm Group Label: Group 3

Other Name: Coloplast

Intervention Type: Procedure

Intervention Name: Hydrogel

Description: All the subjects in this group will be treated with Hydrogel

Arm Group Label: Group 4

Other Name: Coloplast - Purilon Gel

Intervention Type: Procedure

Intervention Name: Ceredak

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

Arm Group Label: Group 5

Eligibility

Criteria:

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

Gender: All

Minimum Age: 35 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Mary Babu, Dr.

Phone: 044-25954913

Phone Ext.: 224

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Diabetes Research Centre Vijay Viswanathan, Dr 044-25954915 277 [email protected] Mary Babu, Dr. Sub-Investigator
Location Countries

India

Verification Date

April 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: M.V. Hospital for Diabetes

Investigator Full Name: Vijay Viswanathan

Investigator Title: MANAGING DIRECTOR

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Group 1

Type: Active Comparator

Label: Group 2

Type: Active Comparator

Label: Group 3

Type: Active Comparator

Label: Group 4

Type: Active Comparator

Label: Group 5

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov