| CTRI Number |
CTRI/2025/02/080771 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The comparison of three different type of dressing to know the best method for healing a diabetic foot ulcer in patients suffering from long term diabetes. |
|
Scientific Title of Study
|
Foam dressing versus saline dressing versus vacuum-assisted closure on wound healing in patients with Wagner’s grade 2 diabetic foot ulcer: A randomized controlled trial |
| 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 CP Pandey |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room No:- 2073 Department of general surgery
Rohilkhand Medical College and Hospital, Philibhit bypass road
243006
Bareilly
UTTAR PRADESH
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9412631348 |
| Fax |
|
| Email |
cppandey19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CP Pandey |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room No:- 2073 Department of general surgery
Rohilkhand Medical College and Hospital, Philibhit bypass road
243006
Bareilly
UTTAR PRADESH
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9412631348 |
| Fax |
|
| Email |
cppandey19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Malay Nigam |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room No:- 2073 Department of general surgery
Rohilkhand Medical College and Hospital, Philibhit bypass road
243006
Bareilly
UTTAR PRADESH
Room No:- 2073
Department of general surgery
Rohilkhand Medical College and Hospital, Philibhit bypass road, Bareilly 243006 UTTAR PRADESH
Bareilly
UTTAR PRADESH
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
08279783945 |
| Fax |
|
| Email |
Malay.nigam.3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
243006
uttar pradesh |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College and Hospital
pilhibhit bypass road
barielly |
| Type of Sponsor |
Private medical college |
|
|
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 CP pandey |
rohilkhand medical college and hospital |
procedure room of FSW(2064) and MSW(2070)
department of general surgery
Rohilkhand Medical
College and Hospital,
Pilibhit bypass road,
243006
Bareilly
UTTAR PRADESH
Bareilly
UTTAR PRADESH |
94126 31348
cppandey19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittee,RMCH,Barielly,UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1
Saline dressing
|
In this group once the debridement of the wound will be done, then the patients will be given saline dressing using normal saline.
daily dressing will be done till the wound become suitable for skin grafting or self healing. |
| Intervention |
Group 3
VAc dressing |
In this type of dressing the vaccum is created over the wound and allow the exudative to escape through the vaccum |
| Intervention |
group2
foam dressing |
In this type of dressing once the debridement is done , dressing is done using the absorbent solutions for the dresing. |
| Comparator Agent |
the 3 groups are comparable to each other |
as above mentioned |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.All the patients of diabetic foot with wegner’s grade 2 diabetic foot ulcer |
|
| ExclusionCriteria |
| Details |
1. Hemodynamically unstable patients.
2. Patients with malignancies and other immunosuppressed conditions.
3. those undergoing corticosteroid or immunosuppressive medication treatment
4. Individuals receiving biological or biochemical therapy, such as those receiving cells or growth factors
5. Individuals with connective tissue disorders, peripheral arterial/venous disease, ulcers with underlying osteomyelitis, coagulopathy, and diseases with poor prognoses
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.the healing will be compared between all the 3 groups so that whether the wound has reached the stage of complete reepthilization. |
1.the healing will be compared between all the 3 groups so that whether the wound has been reached the stage of complete reepthilization at the end of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.healing time |
1.Wound will be seen on weekly basis. |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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)
|
25/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
-Diabetic foot is an important complication associated with diabetes which is among the important causes of disability and mortality in diabetic patients. Diabetic foot ulcer is described as a break in the epidermis and at least a portion of the dermis.
-There is a need of multidisciplinary approach for the management of diabetic foot which includes control of blood sugar, surgícal debridement of the wound, decompressive treatment and vascular recanalization. Preventing and controlling wound infection along with promoting tissue repair is extremely ímportant in preventing the amputation of a diabetíc foot wound.
-In this study we have taken the 3 groups in which the patients are given the different types of wound dressing and them the comparision between them is seen.
-In NS dressing the daily 24hrs dressing will be done whereas, in the other 2 groups ie. the foam dressing and the VAC dressing the dressing is done every week.
- In this we will obsereve the time taken for reepitheilization of the wound for the skin grafting in which there is 100% granulation tissue. |