Diabetic Foot Ulcers Clinical Trial
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Status | Withdrawn |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 |
Verified date | February 2022 |
Source | M.V. Hospital for Diabetes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | Diabetes Research Centre | Chennai | Tamil Nadu |
Lead Sponsor | Collaborator |
---|---|
M.V. Hospital for Diabetes |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | complete healing of the wound | 1 months from the date of application |
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