The purpose of this study was to investigate the effectiveness using excision and grafting (early and delayed) for the treatment of diabetic foot ulcer and comparing it with conventional methods. This non-randomized clinical trial was performed on 50 patients with a history of type 1 or type 2 diabetes presenting for care of a diabetic ulcer of the foot at three teaching hospitals of Shiraz University of Medical Sciences (Ghotboddin, Namazi, and Shahid faghihi) during 6 months period from November 2014 to April 2015. Study inclusion criteria were as follows: age at least 18 years or older; ulcer size>1 and <25 cm2; no clinical signs of systemic infection; adequate circulation to the affected extremity. Patients with index ulcer probing to bone, connective tissue disorders, immune suppressive disorders, severe protein malnutrition, and use of medication that would affect epithelialization were excluded from this study. The patients were divided into two groups. Individuals who referred to Ghotboddin hospital were treated by early and delayed excision and grafting method. On the other group, individuals who referred to Namazi and Shahid Faghihi hospitals were treated by conventional methods. The primary outcome measure was healing status on discharge based on surgeon’s viewpoint. In addition, we considered the number of foot amputation and length of hospital stay as secondary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017103013880N5
Registration date:2017-11-04, 1396/08/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-04, 1396/08/13
Registrant information
Name
Mehdi Ayaz
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 2559
Email address
ayazm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-10-21, 1395/07/30
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison excision and grafting (early and delayed) versus conventional methods in the management of diabetic foot ulcers
Public title
Excision and grafting (early and delayed) for treatment of diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age at least 18 years or older; Ulcer size>1 and <25 cm 2; No clinical signs of systemic infection; Adequate circulation to the affected extremity. Exclusion criteria: Patients with index ulcer probing to bone; Connective tissue disorders; Immune suppressive disorders; Severe protein malnutrition; Use of medication that would affect epithelialization
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Committee of Shiraz University of Medical Sciences
Street address
Headquarters of Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
Approval date
2016-10-04, 1395/07/13
Ethics committee reference number
IR.SUMS.MED.REC.1395.07
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
L97
ICD-10 code description
Ulcer of lower limb
Primary outcomes
1
Description
Healing status
Timepoint
On discharge
Method of measurement
Surgeon’s viewpoint
Secondary outcomes
1
Description
Number of foot amputation
Timepoint
On discharge
Method of measurement
Observation
2
Description
Length of hospital stay
Timepoint
On discharge
Method of measurement
Observation
Intervention groups
1
Description
Individuals who referred to Ghotboddin hospital were treated by early and delayed excision and grafting method
Category
Treatment - Surgery
2
Description
Individuals who referred to Namazi and Shahid Faghihi hospitals were treated by conventional methods
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghotbodin Center for Burn Managemenet and Treatment
Full name of responsible person
Mehdi Ayaz
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Burn Research Center of Shiraz University of Medical Sciences
Full name of responsible person
Mitra Zardasht
Street address
Ghotbodin Hospital
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Burn Research Center of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Ayaz
Position
Assistant Professor of Surgery of Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Ghotbodin Hospital
City
Shiraz
Postal code
Phone
+98 71 3235 9317
Fax
Email
ayazm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Ayaz
Position
Assisstent Professor of Surgery in Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Ghotbodin Hospital
City
Shiraz
Postal code
Phone
+98 71 3235 2559
Fax
Email
ayazm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Ayaz
Position
Assisstent Professor of Surgery in Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Ghotbodin Hospital
City
Shiraz
Postal code
Phone
+98 71 3235 2559
Fax
Email
ayazm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)