| CTRI Number |
CTRI/2025/10/096352 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two treatments surgery Minimal Invasive Metatarsal Osteotomy and dressing with off-loading cast for healing of forefoot ulcers in people with diabetes |
|
Scientific Title of Study
|
Comparative study between Minimal Invasive Metatarsal Osteotomy MIMO vs debridement dressing offloading cast DDO for plantar diabetic forefoot ulcer PDFU A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vishal kumar |
| Designation |
junior resident |
| Affiliation |
AIIMS bibinagar |
| Address |
room no 30 , department of orthopaedics opd block,AIIMS bibinagar Rangapur village,bibinagar mandal (near hyderabad)
room no 30 , department of orthopaedics opd block ,AIIMS bibinagar Rangapur village,bibinagar mandal, (near hyderabad) ,
Hyderabad
TELANGANA
508126
India |
| Phone |
07379922369 |
| Fax |
|
| Email |
vishuk789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Y Ranjith Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS bibinagar |
| Address |
room no 32 , department of orthopaedics opd block,AIIMS bibinagar Rangapur village,bibinagar mandal (near hyderabad)
room no 32 , department of orthopaedics opd block,AIIMS bibinagar Rangapur village,bibinagar mandal (near hyderabad)
Hyderabad
TELANGANA
508126
India |
| Phone |
9000536536 |
| Fax |
|
| Email |
drranjithkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vishal kumar |
| Designation |
junior resident |
| Affiliation |
AIIMS bibinagar |
| Address |
room no 30 , department of orthopaedics opd block,AIIMS bibinagar Rangapur village,bibinagar mandal (near hyderabad)
room no 30 , department of orthopaedics opd block,AIIMS bibinagar Rangapur village,bibinagar mandal (near hyderabad)
Hyderabad
TELANGANA
508126
India |
| Phone |
07379922369 |
| Fax |
|
| Email |
vishuk789@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS bibinagar Rangapur village,bibinagar mandal (near hyderabad) , pincode -508126 , india |
|
|
Primary Sponsor
|
| Name |
AIIMS BBN |
| Address |
AIIMS bibinagar Rangapur village,bibinagar mandal (near hyderabad) , pincode-508126 , india |
| Type of Sponsor |
Government medical college |
|
|
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 |
| vishal kumar |
AIIMS bibinagar |
room no 30 , department of orthopaedics opd block
Hyderabad
TELANGANA |
07379922369
vishuk789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe ( AIIMS BBN-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: L898||Pressure ulcer of other site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DDO debridement dressing offloading cast |
dressing debridement offloading cast for diabetic plantar forefoot ulcer |
| Intervention |
MIMO mimnimally invasive metatarsal osteotomy for diabetic fore foot unlcer over MT head plantar aspect vs dressind debridement offloading cast for some |
give 1 2 cm incision over MT mark the osteotomy location over MT neck with help of k wire osteotomy confirmed with c arm then close the incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 70 years with Wagners classification grade one and two diabetic ulcer under metatarsal head
A single plantar ulcer at the level of metatarsal heads one to five
Patients who consent to the study
|
|
| ExclusionCriteria |
| Details |
Patients with evidence of osteomyelitis or cellulitis or systemic infections & sepsis
Lack of palpable pedal pulses or ankle brachial pressure index less than 0 point 7 and known cases of PVD
Pregnant or lactating women
History of previous major foot surgeries on the same foot for any tumour or trauma
Congenital or aquired foot and ankle deformities causing altered biomechanics of foot
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the healing of ulcer in both groups |
4,8,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare ulcer recurrence within six months between minimal invasive metatarsal osteotomy MIMO vs debridement dressing and offloading cast DDO for plantar diabetic forefoot ulcer
To compare time for healing of ulcer in both the groups
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
27/10/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vishuk789@gmail.com].
- For how long will this data be available start date provided 15-10-2027 and end date provided 02-10-2038?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Public Title
A study comparing two treatments minor bone surgery versus dressing and cast for healing diabetic foot ulcers in the front of the foot
Scientific Title
Comparative study between Minimal Invasive Metatarsal Osteotomy MIMO versus Debridement Dressing and Offloading Cast DDO for Plantar Diabetic Forefoot Ulcer PDFU A Randomised Controlled Trial
Health Condition or Problem Studied
Plantar diabetic forefoot ulcer in patients with diabetes mellitus
Intervention
Group A Minimal Invasive Metatarsal Osteotomy MIMO
Group B Debridement Dressing and Offloading Cast DDO
Primary Outcome
Rate of ulcer healing defined as complete epithelialization without infection or drainage assessed up to 24 weeks
Secondary Outcomes
Time to complete ulcer healing
Recurrence rate of ulcer within 6 months
Functional outcome measured by EFAS Score Foot Function Index and Manchester Oxford Foot Questionnaire
Study Design
Randomized Controlled Trial Parallel group Superiority design
Randomization by computer generated sequence with Serially Numbered Opaque Sealed Envelope method
Sample Size
52 participants total 26 in each group adjusted for 10 percent loss to follow up
Study Duration
October 2025 to October 2027 including 6 month follow up
Study Site
Department of Orthopaedics and Department of Surgery AIIMS Bibinagar Hyderabad Telangana India
Indian Status
Not Yet Recruiting
Global Status
India
Primary Sponsor
All India Institute of Medical Sciences AIIMS Bibinagar Hyderabad Telangana India
Principal Investigator
Dr Vishal Kumar Junior Resident Department of Orthopaedics AIIMS Bibinagar Hyderabad Telangana India |