| CTRI Number |
CTRI/2023/05/052850 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of topical phenytoin for diabetic ulcers |
|
Scientific Title of Study
|
A randomized, open label, parallel, proof of concept study to evaluate efficacy and safety of topical Phenytoin cream in adult patients with Diabetic ulcers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhaskar Krishnamurthy |
| Designation |
Assistant Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Clinical Pharmacology, First floor, New M.S. Building, Seth GSMC and KEM Hosiptal, Acharya Dhonde Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738143524 |
| Fax |
|
| Email |
drbhaskar.kemgsmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhaskar Krishnamurthy |
| Designation |
Assistant Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Clinical Pharmacology, First floor, New M.S. Building, Seth GSMC and KEM Hosiptal, Acharya Dhonde Marg, Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738143524 |
| Fax |
|
| Email |
drbhaskar.kemgsmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhaskar Krishnamurthy |
| Designation |
Assistant Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Clinical Pharmacology, First floor, New M.S. Building, Seth GSMC and KEM Hosiptal, Acharya Dhonde Marg, Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738143524 |
| Fax |
|
| Email |
drbhaskar.kemgsmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swati Spentose Private Limited |
|
|
Primary Sponsor
|
| Name |
Swati Spentose Private Limited |
| Address |
112, Marine Chambers, 11, New Marine Lines, Mumbai - 400020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Bhaskar Krishnamurthy |
Seth GS Medical College and KEM Hospital |
Acharya Dhonde Marg, Parel, Mumbai - 400012
Mumbai
MAHARASHTRA |
7738143524
drbhaskar.kemgsmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - 1 |
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 |
Saline dressing |
Normal saline dressings will be applied topically by the participants once a day over the diabetic wound. |
| Intervention |
Topical phenytoin 1% cream |
Topical phenytoin cream (1 tongue shaped amount to be applied with finger) shall be applied over the diabetic ulcer topically once a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus.
2. Single full-thickness plantar ulcer of the lower extremity (below the knee) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA or II as defined by University of Texas Diabetic Wound Classification).
3. Chronic ulcer of at least six weeks despite appropriate wound care.
4. Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 40 cm², both inclusive.
5. Well controlled infection or cellulitis (with systemic antibiotic therapy).
6. Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test
7. Adequate arterial blood supply, to be measured by ankle brachial pressure index > 0.60, OR ankle systolic pressure > 70 mmHg OR toe pressure > 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification.
8. Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing.
9. Willing to provide written informed consent before any study procedure.
|
|
| ExclusionCriteria |
| Details |
1. Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers.
2. Active ulcer infection assessed by clinical examination and radiographic if necessary.
3. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
4. Active osteomyelitis affecting the area of the target ulcer.
5. Poorly controlled diabetes (uncontrolled glycemia: HbA1c ≥ 12%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL).
6. Known connective tissue or malignant disease.
7. Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
8. Use of any other investigational drug / device within 30 days.
9. Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 7 days.
10. Vascular reconstruction within 8 weeks.
11. Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason.
12. Pregnant or breastfeeding women |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
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 in total ulcer surface area |
8 weeks |
| Incidence of adverse effects |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2023 |
| Date of Study Completion (India) |
14/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/03/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript prepared. To be submitted for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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
|