To compare two different methods of dressing of wounds in the lower limb of diabetic patients following surgical debridement or amputation.
Not Applicable
- Conditions
- Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
- Registration Number
- CTRI/2020/11/029374
- Lead Sponsor
- Christian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All Type 2 Diabetic patient above 18 years of age with post-surgical lower extremity wounds, who have consented to be part of the study.
Exclusion Criteria
1. Patients with bilateral involvement
2. Patients with peripheral vascular disease
3. Patients with coagulopathy
4. Patients suspected to have chronic venous insufficiency.
5. Patients with underlying osteomyelitis.
6. Patients with Charcotâ??s joint
7. Pregnant patients
8. Patients with Chronic kidney disease
9. Patients with Chronic liver disease
10. Patients with a malignancy
11. Patients with coronary artery disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the rate of reduction in size of the post-surgical lower extremity wounds in diabetic patients, undergoing dressings with Mobivac the vacuum assisted closure device and moist wound therapy (Normal saline dressings).Timepoint: To review patients wounds belonging to both arms of the study every week to assess the size of the wounds till they heal completely.
- Secondary Outcome Measures
Name Time Method 1. To compare the time taken for the wounds to heal completely in patients in both arms. <br/ ><br>2.To compare the time taken for the wounds to be covered by granulation tissue in patients in both arms. <br/ ><br>3.Monitor the negative pressures daily from the wound surface in patients in the arm undergoing NPWT using MOBIVAC APP. <br/ ><br>4.To compare the incidence and severity of pain, bleeding and infection in patients belonging to both arms <br/ ><br>Timepoint: Patients belonging to both arms of the study will be reviewed every week to assess the above parameters till the wounds heal completely.