Individualized Homoeopathic intervention in Diabetic Foot Ulcer: a Randomised controlled pilot study using Calendula Q vs normal saline for ulcer dressing

Central Council of Research in Homoeopathy0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

发起方

Central Council of Research in Homoeopathy