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Comparison of the effectiveness of the three methods: healing with dry amniotic dressing, dressing with platelet derived growth factor, and conventional surgical debridement on the improvement of diabetic foot ulcer: a randomized clinical trial

Protocol summary

Study aim
To compare the effectiveness of the three methods: healing with dry amniotic dressing, dressing with platelet derived growth factor, and conventional surgical debridement on the improvement of diabetic foot ulcer
Design
This is a randomized clinical trial, phase II, in which 123 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with diabetic foot ulcer referring to the Imam Hussein Hospital in Tehran city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 70 years, Diabetic foot ulcer with dimension between 1 and 10 cm, Level 1 or 2 based on Vegner scale, HbA1c less than 8, Suitable tissue circulation, Exclusion criteria: Pregnancy or breastfeeding, Osteomyelitis, Malnutrition, Chemotherapy or radiotherapy, Malignancy, Autoimmune diseases, Renal diseases needing dialysis, Immunosuppressive drugs
Intervention groups
Intervention group 1: Wound irrigation and then healing with dry amniotic dressing daily for 10 weeks Intervention group 2: Wound irrigation and then dressing with platelet-derived growth factor daily for 10 weeks Control group: Wound irrigation and then conventional surgical debridement daily for 10 weeks
Main outcome variables
Primary outcome: Improve diabetic foot ulcers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N352
Registration date: 2020-04-21, 1399/02/02
Registration timing: prospective

Last update: 2020-04-21, 1399/02/02
Update count: 0
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of the three methods: healing with dry amniotic dressing, dressing with platelet derived growth factor, and conventional surgical debridement on the improvement of diabetic foot ulcer: a randomized clinical trial
Public title
Comparison of the effectiveness of the three methods: healing with dry amniotic dressing, dressing with platelet derived growth factor, and conventional surgical debridement on the improvement of diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 70 years, Diabetic foot ulcer with dimension between 1 and 10 cm, Level 1 or 2 based on Vegner scale, HbA1c less than 8, Suitable tissue circulation,
Exclusion criteria:
Pregnancy or breastfeeding, Osteomyelitis, Malnutrition, Chemotherapy or radiotherapy, Malignancy, Autoimmune diseases, Renal diseases needing dialysis, Immunosuppressive drugs
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 123
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Shahid Beheshti University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.SBMU.MSP.REC.1398.545

Health conditions studied

1

Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer

Primary outcomes

1

Description
Improve diabetic foot ulcers
Timepoint
In weeks 4, 6, 8 and 10 after the intervention
Method of measurement
With clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Wound irrigation and then healing with dry amniotic dressing daily for 10 weeks
Category
Treatment - Other

2

Description
Intervention group 2: Wound irrigation and then dressing with platelet derived growth factor daily for 10 weeks
Category
Treatment - Other

3

Description
Control group: Wound irrigation and then conventional surgical debridement daily for 10 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hussein Hospital in Tehran city
Full name of responsible person
Dr Majid Tajik
Street address
Imam Hussein Hospital, Shahid Madani Ave.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0734
Email
dr.m.tajik@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Dr Majid Tajik
Position
Resident of General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
School of Medicine, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 8820 2521
Email
dr.m.tajik@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Arash Mohammadi Tofigh
Position
Vascular Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
School of Medicine, Shahid Beheshti University of Medical Sciences, Danshjou Bul.
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 8820 2521
Email
arash_mtofigh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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