CTRI/2019/08/020819Recruiting未知
A single-centric unblinded pilot project to assess the efficacy of local antibiotic delivery using Vitamin D3 granules for complete healing of foot ulcers among diabetic patients
Apollo Hospitals Educational and Research Foundation AHERF0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
Inclusion Criteria
- •1.Diabetes with an HB1A1c of less than or equal to 9%
- •2.No evidence of circulatory compromise
- •3.Posterior tibial or pedal pulse present on palpation
- •4.No pallor on elevation
- •No dependent rubor
- •5Ankle brachial index >0.8
- •6.Loss of sensation on foot using monofilament
- •7.Wound or callus on either one or both feet.
- •8.Wound Classification - Wagner Grade 2 & 3
- •9.Ulcer present for last 1 - 3 months
- •10.Ulcer below the malleoli
- •12. No previous ulcer of that foot or amputation of either extremity
- •13. Wound size 2cm or more than 2cm diameter
Exclusion Criteria
- •Exclusion criteria
- •1.Diagnoses with unpredictable trajectory or healing ability, i.e.
- •2.Psychiatric disorders
- •4.ESRD not eligible for dialysis
- •5.HIV paitient
- •6.Charcot foot
- •Evidence of circulatory compromise
- •7.Absence of pulses
- •8.Decreased capillary refill ( > 3 seconds)
- •9.Ankle Brachial Index < 0.8
Investigators
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