Homoeopathic intervention in diabetic foot ulcer
- 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
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).
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
Name Time Method Complete closure or epithelialisation within 20 weeks of treatmentTimepoint: Complete closure or epithelialisation within 20 weeks of treatment
- Secondary Outcome Measures
Name Time Method 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