Study of topical phenytoin for diabetic ulcers

Completed

• Conditions: Diabetes mellitus due to underlying condition with other specified complications,

• Registration Number: CTRI/2023/05/052850
• Lead Sponsor: Swati Spentose Private Limited

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-06
• Study Completion: 2024-03-14
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of complete ulcer healing	8 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage reduction in total ulcer surface area	8 weeks
Incidence of adverse effects	8 weeks
Time to achieve complete wound closure	8 weeks

Trial Locations

Locations (1)

Seth GS Medical College and KEM Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Seth GS Medical College and KEM Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Bhaskar Krishnamurthy

Principal investigator

7738143524

drbhaskar.kemgsmc@gmail.com