The aim of this longitudinal, rehabitation single arm clinical trial was to evaluate the effectiveness of using autologous PRP gel for diabetic foot ulcer (DFU) treatment. Chronic DFU, considered as a wound in an extremity (mostly foot) of a known diabetic patient which has not decreased by 50% of the primary size in one month. 22 Patients with chronic DFUs after assessment of exclusion criteria : osteomyelitis, malignant arterial insufficiency, history of anti-proliferative medication or radiation in past 3 months, serum Hb<10 mg/dL, platelet count<103/μL and history of growth factor therapy within last 2 weeks and obtaining inform consent were enrolled in the study. In this clinical trial, PRP gel therapy (2ml/cm2 of ulcers) was performed and consequently , size of ulcer was measured before dressing weekly until the healing time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015123018842N10
Registration date:2016-02-07, 1394/11/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 3691
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hematology, Oncology and Stem Cell Transplantation Research Center
Expected recruitment start date
2013-04-20, 1392/01/31
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on effect of PRP-gel application and regular dressing on healing of diabetic wound
Public title
Efficacy of platelet gel on diabetic foot ulcer
Purpose
Supportive
Inclusion/Exclusion criteria
Patients with chronic DFUs were enrolled in the study. Chronic DFU, considered as a wound in an extremity (mostly foot) of a known diabetic patient which has not decreased by 50% of the primary size in one month (Inclusion criteria). No other limitations such as age, sex, fasting blood sugar (FBS) or hemoglobin A1C (Hb A1C) levels were applied.Exclusion criteria included osteomyelitis, malignant arterial insufficiency, exposed bone in an ulcer, antibiotic resistance DFU, wounds with Charcot deformity, history of anti-proliferative medication or radiation in past 3 months, serum Hb<10 mg/dL, platelet count<103/μL and history of growth factor therapy within last 2 weeks.
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hematology, Oncology and Stem Cell Transplantation Research Center
Street address
North Kargar St., Shariat Hospital
City
Tehran
Postal code
1411713135
Approval date
2015-12-24, 1394/10/03
Ethics committee reference number
ir.tums.horcsct.rec.1394.103.3
Health conditions studied
1
Description of health condition studied
Insulin-dependent diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
2
Description of health condition studied
Non-insulin-dependent diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
3
Description of health condition studied
Other specified diabetes mellitus
ICD-10 code
E13
ICD-10 code description
Other specified diabetes mellitus
4
Description of health condition studied
Unspecified diabetes mellitus
ICD-10 code
E14
ICD-10 code description
Unspecified diabetes mellitus
Primary outcomes
1
Description
Ulcer size
Timepoint
weekly up to full healing
Method of measurement
Ruler
Secondary outcomes
1
Description
Efficacy of platelet gel on prevention of foot amputation
Timepoint
mounthly after strat treatment
Method of measurement
visit by surgeon
Intervention groups
1
Description
Dressing of ulcer with Autologous platelet rich plasma gel which is activated by cacl2 (2 ml/cm2 ) weekly up to full healing
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Vascular Surgery of Shariati Hospital
Full name of responsible person
Behnam Molavi
Street address
North Kargar St., Shariati Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hematology, Oncology and Stem Cell Transplantation Reseach Center
Full name of responsible person
Mojtaba Ramezani
Street address
North Kargar St., Shariati Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology, Oncology and Stem Cell Transplantation Reseach Center
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
Hematology, Oncology and Stem Cell Transplantation Resaerch Center
Full name of responsible person
Saeed Mohammadi
Position
PhD
Other areas of specialty/work
Street address
North Kargar St., Shariati Hospital
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
saeedm_58@yahoo.com
Web page address
http://horcsct.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hematology, Oncology and Stem Cell Transplantation Resech Center
Full name of responsible person
Kamran Alimoghaddam
Position
Associate Professor
Other areas of specialty/work
Street address
North Kargar St., Shariati Hospital
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
alimgh@tums.ac.ir
Web page address
http://horcsct.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation
Full name of responsible person
Leyla Sharifi Aliabadi
Position
BSc
Other areas of specialty/work
Street address
North Kargar st,.
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2669
Fax
+98 21 8800 4140
Email
ctu@sina.tums.ac.ir
Web page address
http://horcsct.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)