| CTRI Number |
CTRI/2025/04/085506 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Hyperbaric oxygen therapy in diabetic foot ulcers] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effectiveness of standard treatment for diabetic foot ulcers with and without the use of hyperbaric oxygen therapy |
|
Scientific Title of Study
|
Comparison of treatment of Diabetic Foot Ulcers with and without Hyperbaric Oxygen Therapy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subrata Choudhury |
| Designation |
MCh Student |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Dept. of Plastic Surgery, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9485381694 |
| Fax |
|
| Email |
subrata.agmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nepram Sanjib Singh |
| Designation |
Professor and Guide |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Dept. of Plastic Surgery, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005637634 |
| Fax |
|
| Email |
snepram@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nepram Sanjib Singh |
| Designation |
Professor and Guide |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Dept. of Plastic Surgery, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005637634 |
| Fax |
|
| Email |
snepram@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Subrata Choudhury |
| Address |
Dept of Plastic Surgery, Regional Institute of Medical Sciences, Imphal, Manipur. Pin 795004 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Subrata Choudhury |
Regional Institute of Medical Sciences |
Dept. of Plastic Surgery, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
MANIPUR |
9485381694
subrata.agmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L974||Non-pressure chronic ulcer of heeland midfoot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyperbaric oxygen therapy |
daily 1 hour session, 5 days a week. Patients will receive hyperbaric oxygen therapy for 6 consecutive weeks and results will be assessed after that. |
| Comparator Agent |
Not applicable |
Nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Capacity to make a fully informed decision.
Capacity to give consent for treatment.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of Diabetic foot ulcer |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |