A study to compare efficacy of topical insulin, topical phenytoin and standard wound care for treatment of trophic ulcers in patients with leprosy

Comparative efficacy of topical insulin, topical phenytoin and standard wound care for treatment of trophic ulcers in patients with leprosy: A Hospital Based Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079002

Enrollment

Registered

2025-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L984- Non-pressure chronic ulcer of skin, not elsewhere classified

Interventions

Intervention1: Topical Insulin on trophic ulcer: Application of topical Insulin solution over ulcer along with standard wound care will be done in patients of leprosy as mentioned in the comparator gr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between the age group of 18 to 75 years. 2. Wound area size less than 50 square centimeters. 3. Patients with well controlled diabetes.

Exclusion criteria

Exclusion criteria: 1. Patients not consenting to the study. 2. Patients with malignant ulcers. 3. Patients with gross cellulitis. 4. Patient with underlying osteomyelitis. 5. Patients with lepra reactions. 6. Pregnant and lactating women

Design outcomes

Primary

Measure	Time frame
Clinical response as indicated by percentage of ulcer area reduction between the three treatment groups after 8 weeks.Timepoint: From baseline to the end of follow up at 8 weeks.	—

Secondary

Measure	Time frame
Clinical response as indicated by percentage of ulcers achieving complete healing at the end of 8 weeks in each treatment group.Timepoint: From baseline to the end of follow up at 8 weeks.;Clinical response as indicated by rate of healing of ulcer in each treatment group.Timepoint: From baseline to the end of follow up at 8 weeks.;Assessing the Dermatology Life Quality Index (DLQI) before, during and after completion of 8 weeks.Timepoint: From baseline to the end of follow up at 8 weeks.;Assessing the Physician Global Assessment Score (PGA) before and after completion of 8 weeks.Timepoint: From baseline to the end of follow up at 8 weeks.;Assessing the Incidence of various side effects with Topical Insulin therapy, Topical Phenytoin therapy and Standard Wound Care therapy.Timepoint: From baseline to the end of follow up at 8 weeks.;Assessing the Strength of Association of identified risk factors to wound healing.Timepoint: From baseline to the end of follow up at 8 weeks.	—

Measure

Time frame

Clinical response as indicated by percentage of ulcers achieving complete healing at the end of 8 weeks in each treatment group.Timepoint: From baseline to the end of follow up at 8 weeks.;Clinical response as indicated by rate of healing of ulcer in each treatment group.Timepoint: From baseline to the end of follow up at 8 weeks.;Assessing the Dermatology Life Quality Index (DLQI) before, during and after completion of 8 weeks.Timepoint: From baseline to the end of follow up at 8 weeks.;Assessing the Physician Global Assessment Score (PGA) before and after completion of 8 weeks.Timepoint: From baseline to the end of follow up at 8 weeks.;Assessing the Incidence of various side effects with Topical Insulin therapy, Topical Phenytoin therapy and Standard Wound Care therapy.Timepoint: From baseline to the end of follow up at 8 weeks.;Assessing the Strength of Association of identified risk factors to wound healing.Timepoint: From baseline to the end of follow up at 8 weeks.

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Countries

India

Contacts

Public ContactDr Sunil Kumar Gupta

AIIMS Gorakhpur

dr.sunil_30@yahoo.co.in9838844937

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026