NCT01105884

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

April 16, 2010

Last Update Submit

February 16, 2022

Conditions

Diabetic Foot Ulcers

Keywords

Wound healing, type 2 diabetes, diabetic foot ulcers, different dressings

Outcome Measures

Primary Outcomes (1)

  • complete healing of the wound

    1 months from the date of application

Study Arms (5)

Group 1

ACTIVE COMPARATOR
Procedure: Normal Saline

Group 2

ACTIVE COMPARATOR
Procedure: Biatin Ag (Foam)

Group 3

ACTIVE COMPARATOR
Procedure: Hydrocolloid

Group 4

ACTIVE COMPARATOR
Procedure: Hydrogel

Group 5

ACTIVE COMPARATOR
Procedure: Ceredak

Interventions

Normal SalinePROCEDURE

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

Group 1
Biatin Ag (Foam)PROCEDURE

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

Also known as: Coloplast
Group 2
HydrocolloidPROCEDURE

All the subjects in this group will be treated with Hydrocolloid

Also known as: Coloplast
Group 3
HydrogelPROCEDURE

All the subjects in this group will be treated with Hydrogel

Also known as: Coloplast - Purilon Gel
Group 4
CeredakPROCEDURE

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

Group 5

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Centre

Chennai, Tamil Nadu, 600013, India

Location

MeSH Terms

Conditions

Diabetic FootDiabetes Mellitus, Type 2

Interventions

Saline SolutionColloidsHydrogels

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsComplex MixturesDosage FormsGels

Study Officials

  • Vijay Viswanathan, Dr

    DRC

    PRINCIPAL INVESTIGATOR

  • Rajesh Kesavan, Dr.

    DRC

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MANAGING DIRECTOR

Study Record Dates

First Submitted

April 16, 2010

First Posted

April 19, 2010

Study Start

October 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 4, 2022

Record last verified: 2022-02

Locations

IN(1)