Treatment of bed sore with Platelet rich plasma in patients with spinal cord injury

Phase 1

• Conditions: Health Condition 1: null- Spinal cord injured

• Registration Number: CTRI/2021/09/036188
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Participants with age more than 18 and less than 65 years.

2. Participants or close relative must be able to give voluntary written consent.

3. Participants with sacral PU with <3m duration.

4. Pressure ulcer of grade III & IV will be included in the study.

5. Participant who hospitalized for rehabilitation at ISIC will be included in the study.

Exclusion Criteria

1. Mental, psychiatric or cognitive disorder and /or pre-existing medical condition that might interfere with the outcomes.

2. Pressure sores associated with osteomyelitis, malignancy, leprosy and HIV (+ve)

3. Platelet dysfunction

4. Arterial origin of the cutaneous ulcers.

5. Active vasculitis,

6. Systemic lupus erythematosus, cryoglobulinemia,

7. Hematological abnormality or any coagulation abnormalities.

8. Current use of anticoagulants and/or treatment with immunosuppressant drugs;

9. Serum hemoglobin concentration <11 g/dL or hematocrit <34%;

10. Participant taking drug which might interfere with the study intervention like Anti- neoplastic drugs, steroids, antibiotics etc.

11. Drug or alcohol abuse..

12. Patient who smokes will be excluded from the study.

13. Diabetes (controlled/ Uncontrolled), uncontrolled hypertension, autoimmune disease, renal failure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Size of pressure ulcer (percentage of surface area healed).Timepoint: 5 week and 3 month

Secondary Outcome Measures

Name	Time	Method
Pressure Ulcers Scale for Healing (PUSH) <br/ ><br>Depth of pressure ulcers <br/ ><br>Quality of Life using SF 36 <br/ ><br>4. Participant impression of change using visual analogue scale (VAS) <br/ ><br>5. Clinician impression of change using VAS <br/ ><br>6. Participantsâ?? satisfaction using VAS <br/ ><br>7. Histo-pathological resultsTimepoint: 3 month from the day of randomization