| CTRI Number |
CTRI/2024/02/062560 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of effectiveness of topical phenytoin in healing of diabetic foot ulcers |
|
Scientific Title of Study
|
Evaluation of the effectiveness of sodium phenytoin dressing on wound healing among the patients with Diabetic foot ulcer at Tata Motors Hospital,Jamshedpur |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ponnam Amarnadh |
| Designation |
DNB Trainee |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of General Surgery Tata Motors Hospital Kharangajhar Telco colony
Jamshedpur Purbi Singhbhum district Jharkhand
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
9603036112 |
| Fax |
|
| Email |
amarnadh19971405@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunima Verma |
| Designation |
HOD , Department of General Surgery |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of General Surgery Tata Motors Hospital Kharangajhar Telco colony Jamshedpur Purbi Singhbum Jharkhand
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
9234653775 |
| Fax |
|
| Email |
Arunima.Verma@tatamotors.com |
|
Details of Contact Person
Public Query
|
| Name |
Ponnam Amarnadh |
| Designation |
DNB Trainee |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of General Surgery Tata Motors Hospital Kharangajhar Telco colony
Jamshedpur Purbi Singhbhum district Jharkhand
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
9603036112 |
| Fax |
|
| Email |
amarnadh19971405@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Motors Hospital Kharangajhar Telco colony Jamshedpur East Singhbhum , Jharkhand 831004 |
|
|
Primary Sponsor
|
| Name |
Tata Motors Hospital |
| Address |
Kharangajhar Telo colony
Jamshedpur East Singhbhum
Jharkhand 831004 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ponnam Amarnadh |
Tata Motors Hospital |
Department of General Surgery Kharangajhar Telco colony Jamshedpur Jharkhand 831004
Purbi Singhbhum
JHARKHAND |
9603036112
amarnadh19971405@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, TATA MOTORS HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E086||Diabetes mellitus due to underlying condition with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline dressing |
Conventional dressing will be
done with normal saline.
Dressing will be done once
daily. The patients are to be followed upon daily base for 8 weeks |
| Intervention |
phenytoin dressing |
Injection Phenytoin (50mg/ml) solution will be diluted using normal saline to prepare a solution of 5 mg/ml.
Phenytoin dosage was estimated based on surface area of wound 20mg/cm2 TBSA. Dressing will be done after every 48 hours and followed up for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients with diabetic foot ulcer
irrespective of gender.
2. Both Inpatients and outpatients with Diabetic
foot ulcer. |
|
| ExclusionCriteria |
| Details |
1. Ulcers of other etiology.
2. Other comorbid conditions like renal failure,
generalized debility which adversely affect
wound healing.
3. Patients allergic to phenytoin .
4. patients who are immunocompromised or under
immunosuppression therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of complete ulcer healing. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to achieve complete wound closure |
8 weeks |
| Percentage reduction total ulcer surface area |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
23/02/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 ulcer is a common complication of diabetes. The healing of diabetic foot ulcers depends on multiple factors such as glycemic control, vascularity, bacterial load, location of the wound, nutritional status of the patient, etc. The standard wound care of diabetic foot ulcer relies primarily on pressure relief, debridement and maintenance of a moist wound environment. Phenytoin’s wound healing promoting effect has been attributed to many mechanisms including increasing fibroblast proliferation, inhibiting collagenase activity, promoting collagen deposition, enhancing granulation tissue formation, decreasing bacterial contamination, reducing wound exudates formation and up-regulating growth factor receptors. Biopsies of phenytoin treated wounds show neovascularization, collagenization and decreased polymorphonuclear and eosinophil cell infiltration. Topical phenytoin can enhance wound healing in diabetic foot ulcers but further research is required to establish the role of phenytoin as healing agent. The present study is a proof-of-concept study being conducted on a pilot basis to assess the efficacy of topical phenytoin dressing as compared to conventional wound dressing with normal saline in the healing process of diabetic ulcers, and to determine its efficacy in the management of diabetic ulcers Po
|