| CTRI Number |
CTRI/2025/03/083440 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
3D printed footwear for trophic ulcers |
|
Scientific Title of Study
|
The Impact of Custom 3D Printed Footwear on Diabetic Foot Ulcer Healing: A Randomized 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 |
Ozair Hassan |
| Designation |
Post Graduate, General Surgery |
| Affiliation |
SAVEETHA MEDICAL COLLEGE |
| Address |
Department of General Surgery,Saveetha Medical College ,Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
7010825928 |
| Fax |
|
| Email |
drozairhassan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G Muthukumaran |
| Designation |
Professor, General Surgery |
| Affiliation |
SAVEETHA MEDICAL COLLEGE |
| Address |
2nd floor, Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9840170308 |
| Fax |
|
| Email |
gmkumaran99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ozair Hassan |
| Designation |
Post Graduate, General Surgery |
| Affiliation |
SAVEETHA MEDICAL COLLEGE |
| Address |
2nd floor, Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
7010825928 |
| Fax |
|
| Email |
drozairhassan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105 |
|
|
Primary Sponsor
|
| Name |
Ozair Hassan |
| Address |
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602015 |
| 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 |
| Dr Ozair Hassan |
Saveetha Medical College and Hospital |
2nd floor, Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai - 602105
Chennai
TAMIL NADU |
7010825928
drozairhassan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E106||Type 1 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D PRINTED FOOTWEAR |
The project aims to explore the effectiveness of custom-made 3D printed footwear in promoting the healing of diabetic foot ulcers. This study will compare the healing rates, comfort, usability, and long-term outcomes of patients using 3D printed footwear against those using standard footwear or other treatments. By focusing on how personalized footwear can redistribute pressure on the foot, the trial seeks to determine if this innovative approach can accelerate ulcer healing, enhance patient comfort, and reduce recurrence rates. Additionally, the project will assess the cost-effectiveness and overall patient satisfaction with 3D printed footwear, potentially leading to new advancements in diabetic foot care. |
| Comparator Agent |
Conventional MCR footwear |
Description: Patients in this group will receive standard therapeutic footwear commonly used for diabetic foot care. This includes prefabricated, commercially available offloading footwear or removable cast walkers (RCWs).
Materials: MCR footwear
Usage Protocol: Patients will use the provided standard therapeutic footwear daily during waking hours. Instructions for hygiene, inspection, and maintenance of the footwear will be identical to those given to the intervention group to ensure consistency.
Objectives:
Provide adequate pressure redistribution as per standard diabetic foot care.
Facilitate healing and manage existing ulcers.
Maintain patient comfort and compliance.
Evaluate long-term effectiveness and recurrence rates.
Monitoring: Regular follow-up visits at weeks 2, 4, 8, and 12, mirroring those of the intervention group to ensure parallel data collection.Materials: Biocompatible, lightweight thermoplastic or composite materials with cushioning properties to enhance patient comfort and durability.
Usage Protocol: Patients will wear the 3D printed footwear daily during waking hours, replacing conventional footwear. Patients will be instructed on appropriate footwear hygiene, inspection, and maintenance protocols.
Objectives:
Redistribute plantar pressure effectively.
Accelerate diabetic foot ulcer healing.
Improve patient comfort and adherence.
Prevent ulcer recurrence.
Monitoring: Regular follow-up visits at weeks 2, 4, 8, and 12 to assess wound healing progress, footwear condition, comfort, and any required adjustments. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults 18+ with a diagnosis of diabetes mellitus.
2. Presence of plantar trophic foot ulcers.
3. Ulcer grade 1 or 2 on the Wagner Ulcer classification system.
4. No signs of active infection at the ulcer site.
5. Ability to comply with study procedures and follow-up visits |
|
| ExclusionCriteria |
| Details |
1. Major foot deformities (eg: Charcot foot)
2. Severe peripheral arterial disease.
3. Cognitive impairment preventing informed consent.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved Ulcer Healing Rates
Better Pressure Redistribution
Enhanced Patient Comfort and Satisfaction
Reduced Ulcer Recurrence
Cost-Effectivenes
|
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Enhanced Patient Comfort & Satisfaction
Reduced Ulcer Recurrence
Cost-Effectivenes
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
•The project aims to explore the
effectiveness of custom-made 3D printed footwear in promoting the healing of
diabetic foot ulcers. This study will compare the healing rates, comfort,
usability, and long-term outcomes of patients using 3D printed footwear against
those using standard footwear or other treatments. By focusing on how
personalized footwear can redistribute pressure on the foot, the trial seeks to
determine if this innovative approach can accelerate ulcer healing, enhance
patient comfort, and reduce recurrence rates. Additionally, the project will
assess the cost-effectiveness and overall patient satisfaction with 3D printed
footwear, potentially leading to new advancements in diabetic foot care.
|