â??Effect of leechtherapy in chronic non-healing ulcer
- Conditions
- Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg
- Registration Number
- CTRI/2023/05/052280
- Lead Sponsor
- AIIMS Bhopal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect leech therapy (Hirudotherapy) in comparison to standard of care (SOC) <br/ ><br>management on following subjective and objective parameters <br/ ><br>Subjective Parameters: <br/ ><br>1. Pain <br/ ><br>2. Itching <br/ ><br>3. Burning <br/ ><br>Objective parameters: <br/ ><br>1. Size 2.Tenderness <br/ ><br>3. Smell 4. Granulation <br/ ><br>5. Discharge 6.Colour <br/ ><br>7. Margin and surface 8. Base/Floor <br/ ><br>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 Outcome Measures
Name Time Method To assess the effect leech therapy (Hirudotherapy) in comparison to standard of care (SOC) <br/ ><br>management on following subjective and objective parameters <br/ ><br>Subjective Parameters: <br/ ><br>1. Pain <br/ ><br>2. Itching <br/ ><br>3. Burning <br/ ><br>Objective parameters: <br/ ><br>1. Size 2.Tenderness <br/ ><br>3. Smell 4. Granulation <br/ ><br>5. Discharge 6.Colour <br/ ><br>7. Margin and surface 8. Base/Floor <br/ ><br>9. SwellingTimepoint: secondary outcome will be assessed on every week till 2 month.