Effectiveness of topical insulin vs honey dressing on diabetic foot ulcer among patients with diabetic mellitus
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2021/03/032248
- Lead Sponsor
- Mrs Chandramathi K
- Brief Summary
This study was a randomized, blocked RCT superiority trial, comparing the efficacy of topical insulin Vs honey dressing on diabetic foot ulcer among patients with diabetes mellitus residing in urban and rural population in experimental arm I, III & II, IV.
In Topical insulin dressing**5** units of human actrapid insulin was diluted with 1 ml of normal saline and sprayed into diabetic foot ulcer.. After 5 minutes dry gauze covered over the diabetic foot ulcer. This dressing was applied for 30 minutes once a day for one month.
In Honey dressing commercially purchased 1 ml of honey was poured into sterile bowl and thin layer of gauze is soaked in honey. Soaked honey gauze topically applied over the diabetic foot ulcer as a thin layer. After 5 minutes dry gauze covered over the diabetic foot ulcer. This dressing was applied for 30 minutes once a day for one month.
Topical insulin and honey dressing was applied for 30 minutes once a day for one month.
Wagner Classification of diabetic foot ulcer and Bates Jensen wound assessment tool was used to assess the diabetic foot ulcer in experimental Arm I, II, III and IV.
two Post-test were conducted after intervening topical insulin Vs honey dressing by adopting Bates Jensen wound assessment tool, at the end of day 15 and 30 among patients with Diabetes mellitus in urban and rural populations in experimental Arm I, II, III and IV respectively
Level of diabetic foot ulcer was majority of patients were wound regeneration in pre-test after application of topical insulin and honey dressing, in post-test the level of diabetic foot ulcer were in mild wound healthy, comparing pre-test score in topical and honey dressing the post-test score level was reduced so both the dressing were effective but comparing topical insulin dressing the honey dressing was very effective.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria: Patients with Diabetic mellitus Age group between 30 and 65 years With grade 1 and 2 ulcers selected by using Wagner classification of diabetic foot ulcer Who are willing to participate in the study.
Exclusion Criteria: Patients with Diabetic mellitus Absence of peripheral pulse in dorsalis pedis artery, posterior tibial artery, anterior tibial artery Uncontrolled wound bleeding Severe malnutrition assessed by BMI Anemia and Hypo-proteinemia Severe infection & Burns Immunodeficiency diseases Renal failure Liver dysfunction Ischemic limbs Osteomyelitis Varicose ulcer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound healing after intervening topical insulin and honey dressing will be the primary outcome of this study. Mean Bates wound assessment scale, Time point- 4 weeks | Wound healing after intervening topical insulin and honey dressing will be the primary outcome of this study.
- Secondary Outcome Measures
Name Time Method Mean Bates wound assessment scale Time point- 4 weeks
Trial Locations
- Locations (1)
Monika Diabetic Centre
🇮🇳Erode, TAMIL NADU, India
Monika Diabetic Centre🇮🇳Erode, TAMIL NADU, IndiaDr ThangaveluPrincipal investigator9994522822drethangavelu@yahoo.com