| CTRI Number |
CTRI/2025/04/085953 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Topical extract] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study on Aloe Vera Gel for Healing Foot Wounds in People with Diabetes in India |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL ON THE THERAPEUTIC
EFFECT OF ALOE VERA EXTRACT ON DIABETIC FOOT
ULCERS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahasyaa Adalarasan |
| Designation |
UG Student |
| Affiliation |
Madras Medical College |
| Address |
Institute of Pharmacology
Madras Medical College
E.V.Periyar Salai
Park Town
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9940424219 |
| Fax |
- |
| Email |
surgeonsahasyaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sahasyaa Adalarasan |
| Designation |
UG Student |
| Affiliation |
Madras Medical College |
| Address |
Institute of Pharmacology
Madras Medical College
E.V.Periyar Salai
Park Town
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9940424219 |
| Fax |
- |
| Email |
surgeonsahasyaa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sahasyaa Adalarasan |
| Designation |
UG Student |
| Affiliation |
Madras Medical College |
| Address |
Institute of Pharmacology
Madras Medical College
E.V.Periyar Salai
Park Town
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9940424219 |
| Fax |
- |
| Email |
surgeonsahasyaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-funded
Institute of Pharmacology
Madras Medical College
E.V.Periyar Salai
Park Town
Chennai, Tamil Nadu
India - 600003 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Sahasyaa Adalarasan |
Rajiv Gandhi Government General Hospital |
Male ward #231
Institute of General Surgery
Tower 2
Chennai
TAMIL NADU |
9940424219
surgeonsahasyaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Madras Medical College & RGGGH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Agaragar placebo gel |
Agar-agar powder will be dissolved in water by boiling and then cooled to form a gel-like consistency. |
| Intervention |
Aloe vera extract |
An intervention will be provided topically as an extract, specifically the inner leaf extract of the aloe vera plant, applied immediately after each surgical debridement session throughout the wound healing period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients over 18 with Diabetic foot ulcer (Wagner grades I and II) |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study
Patients with Wagner grades III-V
Patients who are in intensive care
Patients who are pregnant/lactating mothers
Patients diagnosed with liver and renal failure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the proportion of participants achieving complete wound healing following intervention with aloe vera gel. |
The outcome will be assessed at baseline, 2 weeks, and 4 weeks after the initiation of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Diabetic foot ulcers (DFUs) are one of the most severe complications of diabetes, contributing to significant morbidity and mortality. The management of DFUs is challenging, often requiring prolonged treatment and interventions, and is associated with a high risk of amputation. Aloe Vera extract, known for its anti-inflammatory, antibacterial, and wound-healing properties, has been used in various therapeutic contexts. However, its efficacy in treating DFUs remains inadequately explored. This study aims to evaluate the therapeutic impact of Aloe Vera extract on DFUs, potentially offering an alternative or complementary treatment option. |