| CTRI Number |
CTRI/2021/03/032248 [Registered on: 23/03/2021] Trial Registered Prospectively |
| Last Modified On: |
16/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical insulin vs Honey dressing] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of topical insulin vs honey dressing on diabetic foot ulcer among patients with diabetic mellitus |
|
Scientific Title of Study
|
A study to compare the effectiveness of Topical insulin Vs Honey dressing on Diabetic foot ulcer among patients with Diabetic mellitus residing in Urban and Rural population, Erode. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Chandramathi |
| Designation |
Reader |
| Affiliation |
Dhanvantri college of nursing |
| Address |
Dhanvantri college of nursing
Department of Medical & Surgical Nursing,
Division- Medical
Room No-7
Dhanvantri college of nursing
No;1 Ranganoor road
Ganapathypuram
Thiruchengode (tk)
Namakkal (dt)
Namakkal
TAMIL NADU
637303
India |
| Phone |
9600547548 |
| Fax |
|
| Email |
srimathidharshana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Tamilarasi |
| Designation |
Principal |
| Affiliation |
Madha College of Nursing |
| Address |
Madha College of Nursing
Department of Medical & Surgical Nursing,
Division- Medical
Room No-8
Madha Nagar
Somangalam Road
Kunrathur
Dhanvantri college of nursing
No;1 Ranganoor road
Ganapathypuram
Thiruchengode (tk)
Namakkal (dt)
Chennai
TAMIL NADU
600069
India |
| Phone |
9444324251 |
| Fax |
|
| Email |
tamilperumal69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Padmavathi |
| Designation |
Principal |
| Affiliation |
Dhanvantri college of nursing |
| Address |
Dhanvantri college of nursing
Department of Obstetrics & Gynecological Nursing,
Division- Obstetrics Nursing
Room No-1
Dhanvantri college of nursing
No;1 Ranganoor road
Ganapathypuram
Thiruchengode (tk)
Namakkal
TAMIL NADU
637303
India |
| Phone |
9600721211 |
| Fax |
|
| Email |
padmasekar2009@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mrs Chandramathi K |
| Address |
W/O D. Sridhar
585/42 Ganapathygarden
Pallipalayam
Namakkal
Tamilnadu |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Thangavelu |
Monika Diabetic Centre |
Monika Diabetic Centre
Department of Diabetology
Division- Diabetes Foot Care
Room No-5
Vinay Nagar
Nadarmedu
Erode
TAMIL NADU |
9994522822
drethangavelu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dhanvantri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Insulin |
10 units of Human Actrapid insulin mixed in to 1 ml normal saline topically applied to diabetic foot ulcer among patients with diabetic mellitus
for the duration of 30 minutes once a day for one month. |
| Intervention |
Topical insulin Dressing Vs Honey dressing |
Honey -Commercially purchased honey is poured into sterile bowl and thin layer of gauze is soaked in honey, Soaked honey gauze applied over the diabetic wound as a thin layer,After 5 minutes dry gauze covered over the diabetic wound.This dressing will be applied to diabetic foot ulcer area for the duration of 30 minutes once a day for one month. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
Mean Bates wound assessment scale
Time point- 4 weeks
Days -10th day
20th day & 30th day posttest will be conducted
|
Mean Bates wound assessment scale
Time point- 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
29/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
pilot study publication done. topic was A study to compare the effectiveness of topical insulin dressing Vs Honey dressing on diabetic foot ulcer among patients with diabetes mellitus in urban and rural population Erode. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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 respectivelyLevel 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.
|