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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by M.V. Hospital for Diabetes.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Vijay Viswanathan, M.V. Hospital for Diabetes
ClinicalTrials.gov Identifier:
NCT01105884
First received: April 16, 2010
Last updated: April 21, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Diabetic Foot Ulcers
Procedure: Normal Saline
Procedure: Biatin Ag (Foam)
Procedure: Hydrocolloid
Procedure: Hydrogel
Procedure: Ceredak

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by M.V. Hospital for Diabetes:

Primary Outcome Measures:
  • complete healing of the wound [ Time Frame: 1 months from the date of application ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Coloplast
Active Comparator: Group 3 Procedure: Hydrocolloid
All the subjects in this group will be treated with Hydrocolloid
Other Name: Coloplast
Active Comparator: Group 4 Procedure: Hydrogel
All the subjects in this group will be treated with Hydrogel
Other Name: Coloplast - Purilon Gel
Active Comparator: Group 5 Procedure: Ceredak
All the subjects in this group will be treated with Micro-porous Ceramic Wound Dressing
Other Name: Ceredak

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105884

Contacts
Contact: Mary Babu, Dr. 044-25954913 ext 224 babumary2000@yahoo.com
Contact: Vijay Viswanathan, Dr. 044-25954915 ext 277 drvijay@mvdiabetes.com

Locations
India
Diabetes Research Centre Recruiting
Chennai, Tamil Nadu, India, 600013
Contact: Vijay Viswanathan, Dr    044-25954915 ext 277    drvijay@mvdiabetes.com   
Contact: Rajesh Kesavan, Dr.    044-25954913 ext 277    dr_vijay@mvdiabetes.com   
Sub-Investigator: Mary Babu, Dr.         
Sponsors and Collaborators
M.V. Hospital for Diabetes
Investigators
Principal Investigator: Vijay Viswanathan, Dr DRC
Study Director: Rajesh Kesavan, Dr. DRC
  More Information

No publications provided

Responsible Party: Vijay Viswanathan, MANAGING DIRECTOR, M.V. Hospital for Diabetes
ClinicalTrials.gov Identifier: NCT01105884     History of Changes
Other Study ID Numbers: CDS01
Study First Received: April 16, 2010
Last Updated: April 21, 2012
Health Authority: India: Institutional Review Board

Keywords provided by M.V. Hospital for Diabetes:
Wound healing, type 2 diabetes, diabetic foot ulcers, different dressings

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 22, 2014