Comparison of post-surgical infection frequency, mean length of hospital stay, and surgical outcomes between primary and delayed primary stump closure in diabetic patients undergoing below-knee amputation for diabetic foot
To compare frequency of post-surgical infection, mean hospital stay and surgical outcomes following below knee amputation in diabetics using primary closure versus delayed primary closure
Design
Single-centre, randomized, parallel-group interventional trial of 220 diabetic patients undergoing below-knee amputation, with blinded outcome assessment.
Settings and conduct
The study will be conducted at Combined Military Hospital, Rawalpindi, Pakistan. Adult diabetic patients requiring below-knee amputation will be randomized to primary or delayed primary stump closure groups. Outcomes will be assessed by blinded investigators.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diabetic patients aged 18–75 years being on antidiabetic treatment undergoing below-knee amputation for a single non-salvageable infected limb.
Exclusion criteria: advanced cardiac or respiratory disease, planned guillotine amputation, inadequate skin cover for stump formation, loss to follow-up, or refusal to participate.
Intervention groups
Intervention group 1: Primary stump closure. Patients with immediate closure of the stump at the time of surgery.
Intervention group 2: Delayed primary closure.Stump closure is performed 72 hours after surgery and managed with wound wash and dressings.
Main outcome variables
Frequency of surgical site infection (SSI); mean hospital stay after procedure; need for re-admission after infection; revision of the procedure; 28-day mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260612069759N1
Registration date:2026-07-12, 1405/04/21
Registration timing:retrospective
Last update:2026-07-12, 1405/04/21
Update count:0
Registration date
2026-07-12, 1405/04/21
Registrant information
Name
Abdul Wahid
Name of organization / entity
Combined Military Hospital Rawalpindi Pakistan
Country
Pakistan
Phone
+92 332 9851374
Email address
wahidmalik973@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-01, 1403/10/12
Expected recruitment end date
2025-06-30, 1404/04/09
Actual recruitment start date
2025-01-01, 1403/10/12
Actual recruitment end date
2025-06-30, 1404/04/09
Trial completion date
2025-06-30, 1404/04/09
Scientific title
Comparison of post-surgical infection frequency, mean length of hospital stay, and surgical outcomes between primary and delayed primary stump closure in diabetic patients undergoing below-knee amputation for diabetic foot
Public title
Primary vs delayed closure after below-knee amputation in diabetic foot patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All male or female diabetic patients
Aged 18-75 years of age on treatment
Either oral medication or on insulin
Presenting for below knee amputation of a single non-salvageable limb with infection below the level of amputation
Exclusion criteria:
Patients with advanced cardiac or respiratory disease
Those planned for a guillotine amputation
Patients with inadequate skin cover for stump formation
Patients unwilling to be included in the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
220
Actual sample size reached:
220
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients were individually randomized in a 1:1 ratio to either primary closure or delayed primary closure using simple randomization by drawing method. At the time of enrollment, each patient drew a pre-prepared slip indicating allocation to one of the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were not informed of the specific study hypothesis to minimize expectation bias. Outcome assessments were performed by investigators who were blinded to the treatment allocation. Data analysis was also conducted by blinded investigators to ensure objective interpretation of the study results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee, Institutional Review Board Combined Military Hospital Rawalpindi
Street address
Tamiz-ud-din road, lalkurti, Rawalpindi Cantt
City
Rawalpindi
Postal code
46000
Approval date
2024-12-17, 1403/09/27
Ethics committee reference number
1019
Health conditions studied
1
Description of health condition studied
diabetic foot amputation stump
ICD-10 code
Z86.31
ICD-10 code description
Personal history of diabetic foot ulcer
Primary outcomes
1
Description
Surgical Site infection
Timepoint
Postoperative day 7 and 28.
Method of measurement
Clinical wound assessment for pus discharge, foul smell or any signs of infection.
2
Description
Length of hospital stay
Timepoint
At time of discharge from hospital
Method of measurement
Total number of days from surgery to discharge from hospital will be counted
3
Description
Need for readmission after infection.
Timepoint
Within 28 days after surgery
Method of measurement
Follow up visits for infection related readmission and hospital admission record.
4
Description
Revision of the procedure
Timepoint
Within 28 days after surgery
Method of measurement
Below knee amputation stump assessment for requirement of additional surgery
5
Description
28 days mortality
Timepoint
Within 28 days after surgery
Method of measurement
Hospital records and follow-up information
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Primary stump closure. Patients undergoing below-knee amputation with immediate closure of the stump at the time of surgery.
Category
Treatment - Surgery
2
Description
Intervention group 2:Delayed primary stump closure. Patients undergoing below-knee amputation in whom stump closure is performed 72 hours after the initial surgery following wound assessment, wound washing, and antiseptic dressing.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined military Hospital,Rawalpindi
Full name of responsible person
Abdul Wahid
Street address
Tamiz-ud-din road,Lalkurti,Rawalpindi Cantt
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273426
Email
Wahidmalik973@outlook.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital, rawalpindi
Full name of responsible person
Abdul wahid
Street address
Tamiz -ud-din road, lalkurti, Rawalpindi cantt
City
Rawalpindi
Postal code
46000
Phone
+92 332 9851374
Email
wahidmalik973@outlook.com
Grant name
Self
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Combined Military Hospital, Rawalpindi
Full name of responsible person
Abdul Wahid
Position
Resident Surgeon
Latest degree
Bachelor
Other areas of specialty/work
General Surgery
Street address
House number 142, K-1 block, WAPDA Town, Lahore, Punjab, Pakistan
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 332 9851374
Email
Wahidmalik973@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi ,Pakistan
Full name of responsible person
Abdul Wahid
Position
Resident Surgeon
Latest degree
Bachelor
Other areas of specialty/work
General Surgery
Street address
House number 142, K-1 block, WAPDA Town, Lahore, Punjab, Pakistan
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 332 9851374
Fax
Email
Wahidmalik973@outlook.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi ,Pakistan
Full name of responsible person
Abdul Wahid
Position
Resident Surgeon
Latest degree
Bachelor
Other areas of specialty/work
General Surgery
Street address
House number 142, K-1 block, WAPDA Town, Lahore, Punjab, Pakistan
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 332 9851374
Fax
Email
Wahidmalik973@outlook.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
De-identified participant data, study protocol, statistical analysis plan, and final clinical study report related to primary versus delayed primary stump closure in below-knee amputation for diabetic foot will be made available after publication.
When the data will become available and for how long
After Publication of article
To whom data/document is available
medical students and people working in medical institutions
Under which criteria data/document could be used
only for educational purposes not for commercial purposes after publication and approval from primary author
From where data/document is obtainable
Data can be obtained from google drive after sending request to email Wahidmalik973@outlook.com. link for Google drive will be shared to get the data access.
What processes are involved for a request to access data/document
an email will be required and approval will be given by primary author for using the data