A Study of Ayurvedic Krimi Chikitsa Using Maggot Therapy for Management of Diabetic Foot Ulcers

Safety, Efficacy, Acceptability & Tolerability of Krimi Chikitsa w.s.r. to Maggot Debridement Therapy in Madhumehajanya Vrana w.s.r. to Diabetic Foot Ulcer: A Randomized Controlled Pilot Clinical Trial - KCMDT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102444

Enrollment

Registered

2026-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: L974- Non-pressure chronic ulcer of heeland midfoot Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Diabetic Foot ulcers (Wagner grade 1 to 2) Diabetic Foot ulcers (University of Texas grading 0 to 1) 4. Diabetic Foot ulcers (University of Texas stage A to B) Patients with Diabetic Foot Ulcer who were advised below knee amputation. Willing to provide informed written consent for participation in study.

Exclusion criteria

Exclusion criteria: Diabetic Foot ulcers (Wagner grade 3 to 5) Diabetic Foot ulcers (University of Texas grading 2 to 3) Diabetic Foot ulcers (University of Texas stage C to D) Open wounds in large body cavities and wounds in close proximity to large blood vessels. Arterial ulcer or Peripheral Vascular Disease (PVD) or Neuropathic ulcer or Spinal injury Patients allergic to eggs, soybeans or fly larvae.

Design outcomes

Primary

Measure	Time frame
Change in Diabetic Foot Ulcer Assessment ScaleTimepoint: At baseline and end of 8th week	—

Secondary

Measure	Time frame
Change in Score of Bates Jensen Wound Assessment ToolTimepoint: At baseline and end of 8th week;Change in Wagner s classification of diabetic foot ulcersTimepoint: At baseline and end of 8th week;Change in University of Texas classification of diabetic foot ulcersTimepoint: At baseline and end of 8th week;Change in wound surface areaTimepoint: At baseline and end of 8th week;Duration of wound healingTimepoint: At baseline and day of full epithelialization;Proportion of participants achieving full epithelializationTimepoint: At end of 8th week;Assessment of acceptability of Maggot Debridement TherapyTimepoint: At baseline;Assessment of tolerability of Maggot Debridement TherapyTimepoint: After completion of all sittings of Maggot Debridement Therapy;Occurrence of adverse events in both groupsTimepoint: At end of 8th week;Comparison of Number and reasons of loss to follow-ups/drop-outs in both groupsTimepoint: At end of 8th week;Compliance of interventions in both groupsTimepoint: At end of 8th week	—

Measure

Time frame

Change in Score of Bates Jensen Wound Assessment ToolTimepoint: At baseline and end of 8th week;Change in Wagner s classification of diabetic foot ulcersTimepoint: At baseline and end of 8th week;Change in University of Texas classification of diabetic foot ulcersTimepoint: At baseline and end of 8th week;Change in wound surface areaTimepoint: At baseline and end of 8th week;Duration of wound healingTimepoint: At baseline and day of full epithelialization;Proportion of participants achieving full epithelializationTimepoint: At end of 8th week;Assessment of acceptability of Maggot Debridement TherapyTimepoint: At baseline;Assessment of tolerability of Maggot Debridement TherapyTimepoint: After completion of all sittings of Maggot Debridement Therapy;Occurrence of adverse events in both groupsTimepoint: At end of 8th week;Comparison of Number and reasons of loss to follow-ups/drop-outs in both groupsTimepoint: At end of 8th week;Compliance of interventions in both groupsTimepoint: At end of 8th week

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Countries

India

Contacts

Public ContactRajendra Kumar

CCRAS-CARI Bengaluru

rajendra@ccras.nic.in9784361336

Outcome results