Comparison Of Conventional Dressing With Dressing By Diperochloric Solution(Dpocl) For The Healing Of Chronic Diabetic Neuropathic Ulcer – A Randomized Controlled Trial

AIM:

TO COMPARE THE OUTCOME OF CONVENTIONAL DRESSING WITH THE DRESSING BY DIPEREXOCHLORIC (DPOCL) SOLUTION FOR THE HEALING OF CHRONIC DIABETIC NEUROPATHIC ULCER

OBJECTIVES:

1.To assess the time required for complete wound closure of chronic diabetic neuropathic ulcer.

2.To assess the time required for initial response to the treatment of chronic diabetic neuropathic ulcer.

WHY THIS STUDY IS ESSENTIAL?

•DIABETIC FOOT ULCER(DFU) ,A CRITICAL COMPLICATION OF DIABETES MELLITUS IS ASSOCIATED WITH HIGH RISK OF INFECTION ,GANGRENE,AMPUTATION AND DEATH

•

•WOUND DRESSING FORM AN INTEGRAL PART OF THE DFU MANAGEMENT,AND DPOCL CAN BE USED FOR FASTER WOUND HEALING,WOUND CLOSURE,SURFACE AREA REDUCTION AND IMPROVEMENT IN CLINICAL STATUS

•Study Design: RANDOMISED CONTROL TRIAL

•Study Setting (Site): Department of General Surgery , Sir T hospital, Bhavnagar.

•Intervention (if any): yes

•INCLUSION CRITERIA

1. Patient with diabetic chronic(>4WEEKS) Neuropathic   ulcer

age group >18 Years

2. Ulcer size <5cm

3.wagner classification 1-2

• EXCLUSION CRITERIA

1. Pregnant female

2 Lactation

MATERIALS AND METHODS

STUDY DESIGN:

-RANDOMISED CONTROL TRIAL

SOURCE OF DATA

-Patients of diabetic neuropathic ulcer admitted to surgery department or attending surgery OPD of SIR T HOSPITAL

•SAMPLE SIZE-

•at 95% confidence intervals ant 80% power final sample size is 72, 36 in each group

•Study Design: A randomized control trial study.

•Study Population: Patients with diabetic , neuropathic ulcer admitted in wards of General Surgery Department, Sir T Hospital Bhavnagar, Government Medical College, Bhavnagar.

•Brief about study procedures:

ØStudy design: A Randomised control trial

ØStudy duration: 6 Months.

ØInformed written consent from the patient, this randomized controlled clinical study will be carried out on indoor patients in the Department of General Surgery, Government Medical College, Bhavnagar, Gujarat, India.

ØAfter thorough clinical evaluation, patients will be included or excluded according to the Inclusion and Exclusion Criteria.

ØThe study will be conducted my making 2 study groups by paper - chit method

ØSTUDY GROUP A-TEST(DRESSING WITH DPOCL),AND GROUP B-DRESSING WITH NORMAL SALINE

Ø•REGULAR DRESSING WITH DPOCL OR NORMAL SALINE WILL BE APPLIED FOR TREATMENT PERIOD OF 10 WEEKS,

ØThe following data will be collected and recorded from the patient on their first visit:

1. Patients’ General Information including name, age, sex, MRD number.

2. Diagnosis and Treatment Data will be recorded in the form of:

• Duration of diagnosis of wounds over body

• Total duration of medications/therapy taken

• Duration since ulcer formation

• Changes in the size of ulcer before beginning the study adherence to   treatment.

ØThe following data will be collected from the patients in follow up dressing:

§Date based dressing records will be done in written, graphical and to look for changes in size, edge, margin and floor of ulcer.

§Random blood sugar level, frequency of dressing in the past week, adherence to treatment, culture and sensitivity of the wound

•ANALYSIS OF THE WOUND WILL BE DONE AT 4-6 WEEK,6-8WEEK,8-10 WEEK

AND WOUND WILL BE ASSESSED FOR COMPLETE WOUND CLOSURE AND REDUCTION IN WOUND SURFACE AREA BY MEASURING THE SIZE OF WOUND WITH MEASURE TAPE AND VISUAL ASSESSMENT BY TAKING PHOTOGRAPHS

 

METHODOLOGY

• PARTICIPANT SELECTION BASED ON INCLUSION AND EXCLUSION CRITERIA WITH WRITTEN AND INFORMED CONSENT

•SIMPLE METHOD OF GENERATING RANDOM SEQUENCE BY THE PAPER CHIT METHOD

•WITH STUDY GROUP A-TEST(DRESSING WITH DPOCL),AND GROUP B-DRESSING WITH NORMAL SALINE

•REGULAR DRESSING WITH DPOCL OR NORMAL SALINE WILL BE APPLIED FOR TREATMENT PERIOD OF 10 WEEKS,

•ANALYSIS OF THE WOUND WILL BE DONE AT 4-6 WEEK,6-8WEEK,8-10 WEEK

•AND WOUND WILL BE ASSESSED FOR COMPLETE WOUND CLOSURE AND REDUCTION IN WOUND SURFACE AREA BY MEASURING THE SIZE OF WOUND WITH MEASURE TAPE AND VISUAL ASSESSMENT BY TAKING PHOTOGRAPHS

•TABULATION OF DATA IN EXCEL SHEET

•ANALYSIS OF DATA

•TO COMPARE THE COMPLETE WOUND CLOSURE BETWEEN BOTH GROUPS

Risk & Benefits

ØThere are direct benefits to study participants. Diperoxochloric acid (DPOCL, an adduct of peroxochlorate and chlorite) is a bi-functional antibacterial molecule, which is proliferative in Medical Research Council cell strain (MRC)-5 fibroblast cell-lines. It is believed to trigger ulcer healing by disinfecting the wound ground, diminishing germ load to nearly zero within 2 hours and stimulating the fibroblasts. leading to faster wound healing and wound closure and improvement in clinical status

ØSociety will be benefited by reducing hospital stay duration.

ØThere is no physical, psychological or social risk to study participants.