â??Effect of leech therapy in chronic non-healing ulcer"

â??Effect of medicinal leech therapy (Hirudotherapy) in chronic non-healing ulcer: A prospective open label, randomized comparative clinical studyâ??

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052280

Enrollment

Registered

2023-05-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg

Interventions

Intervention1: Medicinal leech(Hirudo medicinalis): Single session of leech therapy will be given to participants once a week for 2 months or till complete healing, whichever is earlier. 2 to 3 leeche

Eligibility

Inclusion criteria

Inclusion criteria: o Patient suffering from chronic ulcer (wounds more than 4 weeks) on any part of the body o Subject diagnosed with Grade1 and Grade 2 (Wagnerâ??s classification) of non-healing ulcer o Age group of 18 to 65 years. o Both male and female patients will be included. o Chronic non-specific ulcers, varicose ulcers, trophic ulcer, pressure sores, diabetic foot ulcer will be included. o Abscess wounds. o Patient willing to take part in this study.

Exclusion criteria

Exclusion criteria: o Fresh tidy wound will be excluded. o Patients of non-healing ulcer of > grade 2 of Wagnerâ??s classification. o Patients suffering with serious systemic illness will also be excluded. o Uncontrolled diabetic patients o Malignant ulcer o Tubercular ulcer o Any sign of gangrene o HIV, HBsAg, HCV Reactive Patients o Underlying bony lesions will be excluded. o Highly immune compromised patients o Age less than 18 years and more than 65 years.

Design outcomes

Primary

Measure	Time frame
To assess the effect leech therapy (Hirudotherapy) in comparison to standard of care (SOC) management on following subjective and objective parameters Subjective Parameters: 1. Pain 2. Itching 3. Burning Objective parameters: 1. Size 2.Tenderness 3. Smell 4. Granulation 5. Discharge 6.Colour 7. Margin and surface 8. Base/Floor 9. SwellingTimepoint: Primary outcome will be assessed on every week till 2 month that mean at baseline , on 7th day, on 14th day, on 21st day and on 28th day	—

Measure

Time frame

To assess the effect leech therapy (Hirudotherapy) in comparison to standard of care (SOC) management on following subjective and objective parameters Subjective Parameters: 1. Pain 2. Itching 3. Burning Objective parameters: 1. Size 2.Tenderness 3. Smell 4. Granulation 5. Discharge 6.Colour 7. Margin and surface 8. Base/Floor 9. SwellingTimepoint: Primary outcome will be assessed on every week till 2 month that mean at baseline , on 7th day, on 14th day, on 21st day and on 28th day

—

Secondary

Measure	Time frame
To assess the effect leech therapy (Hirudotherapy) in comparison to standard of care (SOC) management on following subjective and objective parameters Subjective Parameters: 1. Pain 2. Itching 3. Burning Objective parameters: 1. Size 2.Tenderness 3. Smell 4. Granulation 5. Discharge 6.Colour 7. Margin and surface 8. Base/Floor 9. SwellingTimepoint: secondary outcome will be assessed on every week till 2 month.	—

Measure

Time frame

To assess the effect leech therapy (Hirudotherapy) in comparison to standard of care (SOC) management on following subjective and objective parameters Subjective Parameters: 1. Pain 2. Itching 3. Burning Objective parameters: 1. Size 2.Tenderness 3. Smell 4. Granulation 5. Discharge 6.Colour 7. Margin and surface 8. Base/Floor 9. SwellingTimepoint: secondary outcome will be assessed on every week till 2 month.

—

Countries

India

Contacts

Public ContactDr Barkati Md Tarique

All India Institute of Medical Sciences, Bhopal

barkati.ayush@aiimsbhopal.edu.in9270613900

Outcome results

None listed

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