1. Home
  2. Approved trials
  3. » فارسی

Efficacy of Vacuum-Assisted Closure therapy versus Conventional Dressing in the management of Diabetic Foot Ulcer

Protocol summary

Study aim
Comparison between Negative-Pressure Wound Therapy and Conventional Dressing Therapy in Healing Patients with Infected Diabetic Foot Ulcer
Design
patients were randomly assigned to the study groups. Based on the Bland-Altman plot [and similar studies], 30 patients were assigned to each of the intervention and control groups
Settings and conduct
This RCT was conducted on all patients admitted to Modarres Hospital, Tehran, Iran in 2018 or 2019 who have been diagnosed with infected DFU.
Participants/Inclusion and exclusion criteria
diabetic patients with DFU in Modarres Hospital, Tehran, Iran between 2018- 2019 ؛ Patients with vascular diseases, coagulopathies, non-debrided wounds, sepsis, some inabilities, and those who were unwilling to participate in the study were excluded.
Intervention groups
After matching the patients for age and gender, they were randomly assigned to the Vacuum-Assisted Dressing (VAC) and the Silver Sulfadiazine Ointment Dressing groups. The intervention started immediately after the surgical debridement. Wagner’s grading system was used to classify the ulcers based on their surface and depth. The exact date and time of each debridement procedure was recorded to calculate the healing time. In the VAC group, the dressings were changed every 48 hours; however, in the control group, they were changed twice a day. The patients were followed up until the wounds were closed. The healing times, the wounds’ surface areas, along with demographic information of patients, as well as possible complications were recorded in a checklist.
Main outcome variables
Healing speed ؛DFU-related complications ؛The ulcer size

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160803029181N6
Registration date: 2019-10-01, 1398/07/09
Registration timing: registered_while_recruiting

Last update: 2019-10-01, 1398/07/09
Update count: 0
Registration date
2019-10-01, 1398/07/09
Registrant information
Name
Nasser Malekpour Alamdari
Name of organization / entity
Shaid Behesht University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4089
Email address
nassermalekpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Vacuum-Assisted Closure therapy versus Conventional Dressing in the management of Diabetic Foot Ulcer
Public title
Efficacy of Vacuum-Assisted Closure therapy versus Conventional Dressing in the management of Diabetic Foot Ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diabetic patients with infected DFU.
Exclusion criteria:
vascular diseases coagulopathies non-debrided wounds sepsis some inabilities those who were unwilling to participate in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
After matching the patients for age and gender, they were randomly assigned to the Vacuum-Assisted Dressing (VAC) and the Silver Sulfadiazine Ointment Dressing groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commity of Shahid Beheshti University of Medicasl Sciences
Street address
Daneshju Avenue Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-08, 1398/02/18
Ethics committee reference number
IR.SBMU.MSP.REC.1398.089

Health conditions studied

1

Description of health condition studied
infected diabetes mellitus with foot ulcer
ICD-10 code
L97
ICD-10 code description
Non-pressure chronic ulcer of lower limb, not elsewhere classified

Primary outcomes

1

Description
efficacy of dressing with negative pressure
Timepoint
From the initial debridement to the wound healing
Method of measurement
Physical examination

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: treatment with negative pressure dressing will be done.
Category
Treatment - Devices

2

Description
Control group: dressing with silver sulfadiazine ointment will be done.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Nasser Malekpour
Street address
Modarres Hospital;Kaj Sq;Saadat Abad;
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Email
nassermalekpour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Ali Ziai
Street address
Danshju Ave Velenjak
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
aliziai@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical sciences
Proportion provided by this source
100
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Vascular Surgeon Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
ShahidBeheshti University Of Medical Sciences,Arabi street,Velenjak.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2207 4088
Fax
Email
nassermalekpour@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular&laparoscopy
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular&laparoscopy
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...