To compare effectiveness of standard treatment for diabetic foot ulcers with and without the use of hyperbaric oxygen therapy

Not yet recruiting

• Conditions: Non-pressure chronic ulcer of heeland midfoot,

• Registration Number: CTRI/2025/04/085506
• Lead Sponsor: Subrata Choudhury

Brief Summary

A randomized control study of the patients presenting with diabetic foot ulcers will be carried out in the Department of Plastic Surgery, RIMS, Imphal. All the patients with diabetic foot ulcer will be randomly allocated in 2 groups. Group A will undergo treatment with HBOT whereas group B will not. The patients will be studied in terms of the demographic profile to analyse which group of the population is at highest risk for such ulcers. The pattern of ulcer, which includes the duration of ulcer, surface area and site of the ulcer, glycemic status, signs of ischaemia and infection, wagner grading, healing time and rate will also be studied. Last but not the least, the total number of HBOT sessions, changes after HBOT and number of follow up visits required will be noted.

All the findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analysed and inference drawn to evaluate if there is any relation between a particular group of the population based on gender, occupation or age group, to the healing of ulcer after HBOT and functional outcome.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-23
• Study Start: 2025-06-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Capacity to make a fully informed decision.
• Capacity to give consent for treatment.

Exclusion Criteria

• Individuals not fit for Hyperbaric Oxygen Therapy.
• Ulcers less than 1 cm square.
• Lack of patient’s approval for participation in the trial.
• Acute ischemia of lower extremity, profound phlebothrombosis, infection that needed generalized antibiotic therapy.
• Patients having hyperglycemia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healing of Diabetic foot ulcer	6 weeks

Trial Locations

Locations (1)

Regional Institute of Medical Sciences; 🇮🇳 West, MANIPUR, India

Regional Institute of Medical Sciences

🇮🇳West, MANIPUR, India

Subrata Choudhury

Principal investigator

9485381694

subrata.agmc@gmail.com