Health Condition 1: I738- Other specified peripheral vascular diseases
Conditions
Interventions
Intervention1: First arm is the intervention group in which patients will receive platelet gel application topically to wound and PRP injection in and around the wound along with standard care: applic
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.All patients, in age group 18-70 yrs with diabetic ulcers and peripheral artery disease. 2.Patients who give written informed consent. 3.Diabetes patients with PAD 4.Patients with an ulcer of at least 4-weeks 5.Wound area (length x width) measurement between 0.5 and 10 cm2
Exclusion criteria
Exclusion criteria: 1.Patients who are unwilling to provide informed consent. 2.Patients who are less than 18 or greater than 70yr 3.Peripheral venous disease in the lower limbs 4.Recent DVT less than 6 months 5.Uncontrolled Diabetes mellitus 6.Pregnancy 7.Any malignancy 8.Uncontrolled local infection 9.Platelet count 2.0 lacs 10.Patients with severe cardiovascular disorder 11.Gangrene of foot or leg 12.Grossly infected and necrosed wounds and wounds cellulitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of ulcer healing measured as number of weeks required to achieve complete healing 2.Rate of ulcer healing measured as change in wound surface areaTimepoint: every week for one month, two weekly for next two months and monthly till wound heals completely | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement in Absolute walking distance 2.Increase in distal blood flow measured by Ankle Brachial Pressure Index(ABPI) 3.Pain score on scale of 0-10 using Visual Analogue Scale 4.Quality of life 5.Change in incidence of adverse events Timepoint: every week for one month, two weekly for next two months and monthly till wound heals completely | — |
Countries
India
Contacts
Public ContactDr Anita Dhar
All India Institute of Medical Sciences
Outcome results
None listed