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Homoeopathic intervention in diabetic foot ulcer

Phase 3
Conditions
Health Condition 1: null- Diabetic foot ulcer
Registration Number
CTRI/2013/11/004139
Lead Sponsor
Central Council of Research in Homoeopathy
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

i.Men and women aged 18 to 70 years, extremes included with Type 1 or Type 2 Diabetes Mellitus on standard conventional treatment

ii.Single diabetic foot ulcer at or below the malleoli

iii.Diabetic foot ulcer Wegnar 1-2 stage

iv.Chronic ulcer of at least four weeks duration but not more than 3 months

v.Ulcer size (greatest length by greatest width) at randomization between 1.0 cm2 to 10 cm2, both inclusive.

vi.Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index 0.60, or ankle systolic pressure 70 mmHg or toe pressure 30 mmHg

vii.Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test

viii.HbA1C <= 8%

ix.Controlled Hypertension

x.Women surgically sterile, post-menopausal, or agree to practice adequate contraception.

xi.Written Informed consent from the patient

The patients shall continue to take standard allopathic treatment for Diabetes Mellitus and hypertension (in consultation with consultant engaged in study).

Exclusion Criteria

i.Wagner grade 0, 3, 4 and grade 5

ii.Cases presenting with long term complication of diabetes such as severe retinopathy, severe renal involvement or with history of recurrent acute complications like hypoglycemia, ketoacidosis, polyneuropathy etc.

iii.Alcohol addiction or dependence

iv.Subjects with ill managed diabetes i.e. glycosylated hemoglobin (HbA1c) more than 8%.

v.Cases with severe coronary, cerebral, renal vascular, liver diseases as well as malignant neoplasms

vi.Subjects deemed unfit by the investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Complete closure or epithelialisation within 20 weeks of treatmentTimepoint: Complete closure or epithelialisation within 20 weeks of treatment
Secondary Outcome Measures
NameTimeMethod
â?¢To compare the changes in quality of life using Diabetic Foot Ulcer Scale-Short form (DFS-SF) at 12 and 20 weeksTimepoint: 12 and 20 weeks;To compare the change in size of wound area at 4, 8, 12, 16 and 20 weeksTimepoint: 4, 8, 12, 16 and 20 weeks
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