To compare the effectivity of negative pressure wound therapy (NPWT) versus standard modern wound care with moist dressings for treatment of diabetic ulcers in patients with type-II diabetes presenting to a tertiary care hospital.
Design
Two arm parallel group, randomized controlled trial with blinded outcome assessment of 190 total patients assessed for 12 weeks post treatment
Settings and conduct
Since procedural limitations did not allow blinding during the study, the endpoint of wound healing and size regression was assessed by an independent team of 3 consultants who were given the final results of the wounds in pictorial form to give their opinion of the changes before and after treatment and debridement. Both the assessors and the final analysis consultant was unaware of this double blinded study protocol
Participants/Inclusion and exclusion criteria
We made two groups of 95 patients each, one to receive standard dressing care and one to receive NPWT
Inclusion criteria included all patients >18 years diagnosed clinically and blood sugar fasting and 2-hour-post prandial investigations in the diabetic range according to the (World Health Organization) WHO criteria presenting with a diabetic foot wound of more than 4 weeks duration corresponding to Wagner grade 2 for debridement.
Exclusion criteria included patients with pregnancy, non-compliant to follow-up, necrotic tissue on ulcer with eschar that could not be debrided, malignancy, advanced cardiac and respiratory disease, exposed nerve and vessels beneath the ulcer
Intervention groups
Patients in Group N received NPWT (negative pressure wound therapy).
Patients in Group S received standard modern moist wound dressing after debridement
Main outcome variables
Wound closure frequency, wound closure mean time, incidence of infection and amputation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231201060234N2
Registration date:2024-07-08, 1403/04/18
Registration timing:retrospective
Last update:2024-07-08, 1403/04/18
Update count:0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
Rashid Ali
Name of organization / entity
Bolan medical college quetta
Country
Pakistan
Phone
+92 81 2850639
Email address
rashid_zahidbaloch@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-01, 1401/10/11
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
2023-01-01, 1401/10/11
Actual recruitment end date
2023-06-30, 1402/04/09
Trial completion date
2023-06-30, 1402/04/09
Scientific title
Comparison between negative pressure wound therapy versus standard wound care in diabetic foot patients at a tertiary care hospital
Public title
Negative pressure versus standard wound therapy for diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Included all patients >18 years diagnosed clinically and BSF and 2-hour-post prandial investigations in the diabetic range according to the WHO criteria
Presenting with a diabetic foot wound of more than 4 weeks duration corresponding to Wagner grade 2 for debridement.
Exclusion criteria:
Included patients < 18 years
Pregnancy
Non-compliant to follow-up
Necrotic tissue on ulcer with eschar that could not be debrided
Malignancy, advanced cardiac and respiratory disease
Exposed nerve and vessels beneath the ulcer and patient with above ankle ulcer and those with Charcot arthropathy.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Actual sample size reached:
190
Randomization (investigator's opinion)
Randomized
Randomization description
We made two groups of 95 patients each, one to receive standard dressing care and one to receive NPWT randomized through non-probability consecutive sampling via lottery method according to the inclusion criteria furnished. Simple randomization was done. Allocation concealment was carried out through envelopes and residents unaware of the study protocol
Blinding (investigator's opinion)
Double blinded
Blinding description
Since procedural limitations did not allow blinding during the study, the endpoint of wound healing and size regression was assessed by an independent team of 3 consultants who were given the final results of the wounds in pictorial form to give their opinion of the changes before and after treatment and debridement. Data analysis consultant was also blinded to the study protocol with data given as Group N and Group S
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical review board CMH Peshawar
Street address
CMH Road
City
Peshawar
Postal code
25000
Approval date
2022-12-22, 1401/10/01
Ethics committee reference number
CMH-PSC-004356
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcers
ICD-10 code
Z86.31
ICD-10 code description
Personal history of diabetic foot ulcer
Primary outcomes
1
Description
Mean wound closure time
Timepoint
During or after 12 weeks of therapy
Method of measurement
Subjective assessment by 3 consultants
Secondary outcomes
1
Description
Median pain scores
Timepoint
After 12 weeks of therapy
Method of measurement
Standard Visual Analog Scale for pain and Likert scale for satisfaction
2
Description
Incidence of infection
Timepoint
During 12 weeks of therapy
Method of measurement
Subjective by 3 independent consultants
Intervention groups
1
Description
Intervention group: Negative pressure wound therapy group (NPWT) (n=95) Patients in Group N received NPWT after debridement on admission in the hospital and were followed up for 12 weeks to assess for complete healing with 100% epithelization and fit for surgical closure. A standard sub-atmospheric pressure of 120 mmHg was applied on the debrided ulcer through a sealed wound attached to a suction pump. Patients were followed up for up to 12 weeks and primary and secondary variables noted by an independent surgical consultant unaware of the study protocol.
Category
Treatment - Other
2
Description
Intervention group: Standard moist wound therapy group (n=95) Patients in Group S received standard modern moist wound dressing after debridement and followed up for the same after complete epithelization and tissue formation for up to 12 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
CMH Peshawar
Full name of responsible person
Dr. Rashid
Street address
CMH Road
City
Peshawar
Postal code
25000
Phone
+92 333 3384051
Email
rashid_zahidbaloch@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Peshawar
Full name of responsible person
Dr Rashid Baloch
Street address
CMH Road
City
Peshawar
Postal code
25000
Phone
+92 333 3384051
Email
rashid_zahidbaloch@hotmail.com
Grant name
None
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
CMH Peshawar
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
CMH Rwp
Full name of responsible person
Rashid Ali
Position
PG Gen surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
D7
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 81 2850639
Fax
Email
Rashid_zahidbaloch@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH Rwp
Full name of responsible person
Rashid Ali
Position
PG Gen surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
D7
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 81 2850639
Fax
Email
Rashid_zahidbaloch@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
CMH Rwp
Full name of responsible person
Rashid Ali
Position
PG Gen surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
D7
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 81 2850639
Fax
Email
Rashid_zahidbaloch@hotmail.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
The word file along with SPSS data set and output sheet would be shared once the article gets accepted and published
When the data will become available and for how long
Will be available after manuscript approval and would be able to download and use for five years
To whom data/document is available
only for academic purposes
Under which criteria data/document could be used
will be provided after official approval from primary author through email and link would be sent to download the data set from online backup repository
From where data/document is obtainable
Application to access data through official email of the primary author provided in the trial
What processes are involved for a request to access data/document
will be provided after official approval from primary author through email and link would be sent to download the data set from online backup repository
total time would be 7-10 working days