Health Condition 1: null- Diabetic foot ulcer
Conditions
Interventions
Intervention1: Individualized homoeopathic medicine with ulcer dressing using Calendula Q: Medicine shall be given in 6c, 30c, 200c or 1M potency to be taken orally as per the prescribing totality of
Sponsors
Central Council of Research in Homoeopathy
Eligibility
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete closure or epithelialisation within 20 weeks of treatmentTimepoint: Complete closure or epithelialisation within 20 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Chetna Deep Lamba
Central Council of Research in Homoeopathy
Outcome results
None listed