A clinical trial to determine whether local application of autologous bone marrow injections can help in healing chronic wounds

Phase 4

• Conditions: Chronic wounds in an adult Indian population

• Registration Number: CTRI/2009/091/000250
• Lead Sponsor: Christian Medical College, Vellore, Tamil Nadu, India

Brief Summary

This study is a randomized, single blinded, placebo controlled parallel group trial assessing whether local application of autologous bone marrow derived cells to chronic wounds will augment their healing. The primary outcome is rate of wound healing as measured by decrease in wound size over 3 months. The secondary outcome is standardization of the technique of local application of autologous bone marrow derived cells to chronic wounds.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

• Male or female patients with chronic wounds that had not healed for 3 months or more.
• Wounds where primary closure could not be achieved.
• Wounds which were unsuitable for skin grafting.

Exclusion Criteria

• Wounds with active infection defined as copious pus discharge from the wound.
• Wounds where distal pulses were not palpable Wounds more than 15 cm in any one dimension.
• Patients with Hansen?s disease.
• Patients who were pregnant.
• Patients who were on chemotherapy.
• Patients who were diagnosed with hematological disease.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of wound healing as defined by a decrease in wound size over time	Follow up every 2 weeks for 3 months

Secondary Outcome Measures

Name	Time	Method
Standardization of technique of local application of bone marrow cells to chronic wounds	Follow up every 2 weeks for 3 months

Trial Locations

Locations (1)

Department of Surgery Christian Medical College, Vellore Tamil Nadu, India 632004; 🇮🇳 Vellore, TAMIL NADU, India

Department of Surgery Christian Medical College, Vellore Tamil Nadu, India 632004

🇮🇳Vellore, TAMIL NADU, India

Benjamin Perakath

Principal investigator

sur5@cmcvellore.ac.in