CTRI

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CTRI Number

CTRI/2024/07/070984 [Registered on: 22/07/2024] Trial Registered Prospectively

Last Modified On:

06/08/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

longitudinal study

Study Design

Other

Public Title of Study

To determine the efficacy of negative pressure wound therapy (NPWT) in promoting wound healing of diabetic foot ulcer.

Scientific Title of Study

Conventional silver colloidal dressing combined with local insulin application VS negative pressure wound therapy in regular management of diabetic foot ulcer

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Arohi Utkarsh
Designation	Junior Resident
Affiliation	Kasturba hospital, Manipal
Address	3rd floor, Department of general surgery, Smt. Sharada Madhav Pai, OPD building, Kasturba hospital, Manipal Udupi KARNATAKA 576104 India
Phone	7549261585
Fax
Email	arohi.kmcmpl2023@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Annapa Kudva
Designation	Professor and Unit Head
Affiliation	Kasturba hospital, Manipal
Address	3rd floor, Department of general surgery, Smt. Sharada Madhav Pai, OPD building, Kasturba hospital, Manipal, Udupi Udupi KARNATAKA 576104 India
Phone	9448857394
Fax
Email	annappakudva57@gmail.com

Details of Contact Person
Public Query

Name	Dr Jithin Abraham Jacob
Designation	Assistant Professor
Affiliation	Kasturba hospital, Manipal
Address	3rd floor, Department of general surgery, Smt. Sharada Madhav Pai, OPD building, Kasturba hospital, Manipal, Udupi Udupi KARNATAKA 576104 India
Phone	9632823146
Fax
Email	jithin.abraham@manipal.edu

Source of Monetary or Material Support

3rd floor, Department of general surgery, Smt. Sharada Madhav Pai, OPD building, Kasturba Hospital, Manipal, Udupi, Karnataka 576104 India.

Primary Sponsor

Name	NIL
Address	NIL
Type of Sponsor	Other [Not applicable]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Arohi Utkarsh	Kasturba Hospital, Manipal	3rd floor, Department of general surgery, Smt. Sharada Madhav Pai, OPD building, Kasturba hospital, Manipal Udupi KARNATAKA	7549261585 arohi.kmcmpl2023@learner.manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba medical college and Kasturba hospital institutional ethics committee- 2	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M958\|\|Other specified acquired deformities of musculoskeletal system,

Intervention / Comparator Agent

Type	Name	Details
Intervention	nil	nil
Comparator Agent	nil	nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1) Diabetic patient 2) Willing to participate in study 3) Grade 2 3 4 Diabetic foot ulcer according to Wagner classification

ExclusionCriteria

Details

1) Non diabetic foot ulcer.
2) Grade 1 and 5 Diabetic foot ulcer according to Wagner classification
3) Pregnant women
4) Necrotic tissue with existing eschar that could not be debrided.
5) Bleeding disorders.
6) Peripheral vascular disease or monophasic on doppler
7) Patient with proven venous ulcer and malignancy.

Method of Generating Random Sequence

Other

Method of Concealment

Other

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To determine the efficacy of negative pressure wound therapy (NPWT) in promoting wound healing of diabetic foot ulcer Vs Conventional silver colloidal dressing combined with local application of insulin.	Wound will be inspected on day 0 and day 8

Secondary Outcome

Outcome	TimePoints
total cost in treatment.	total cost will be calculated on day 8

Target Sample Size

Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

01/08/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Yet Recruiting

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

After written informed consent is obtained, data will be collected from suitable patients according to the inclusion and exclusion criteria n the department of general surgery KH Manipal. Appropriate history is taken and measurements of ulcer are documented using sterile paper ruler. Wound size is calculated by taking longest diameter (a) in mm and multiplying with its perpendicular diameter (b) and the depth (c) so that the total volume of the wound is obtained in mm3. 29 subjects will be included in each group. In group 1 -Patient will be treated with silver colloidal combined with local application of insulin daily dressing and wound will be assessed on day 8. In group 2 Patient will be treated with NPWT and wound will be assessed on day 8. The outcome will be measured based on percent reduction in wound size between group 1 and group 2. Rate of wound healing is calculated as difference between the wound volume on day 0 and day 8 and is reported in terms on mm3. Data is tabulated and percentage reduction in the size of the ulcer is compared.