Objectives: To determine the effect of heparin therapy on healing chronic wound of diabetic foot in diabetic patients hospitalized in Rasht Razi hospital
Design: In a single-blind randomized controlled clinical trial on 136 patients with chronic diabetic foot ulcers referred to Razi Hospital clinics will be enrolled in the study. The patients with inclusion criteria were randomly divided into two groups of 68 subjects. They will be unaware of the allocation of the two groups.
Setting and conduct: Diabetic patients will be evaluated in terms of chronic diabetic foot ulcers, and if they have medically approved chronic diabetic foot ulcers, they will be reviewed in inclusion and exclusion criteria.
Participants including major eligibility criteria
Inclusion criteria:
1. Recent chronic neuropathic wounds in diabetic foot (less than 10 days)
2. wound with degree 1 based on Wegener scale or debrided or limited amputated patients with degree 2, 3 and 4
3- ABI<0.9 (without ischemic or neuroischemic diabetic foot ulcer)
4. Open wound or debrided or limited amputated patients
Exclusion criteria:
1.The existence of chronic diabetic foot ulcers caused by ischemia
2-The patient under treatment with anticoagulant therapy at the time of enrollment
3-Contraindications in low molecular weight heparin administration, including severe renal impairment, liver failure Child-Pugh class B or C, having bleeding disorders and proliferative diabetic retinopathy of bleeding risk
Interventions: Daily injection of low molecular weight heparin injections of 40 mg for 30 days
Main outcome: Diabetic foot ulcers
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120130508N2
Registration date:2017-04-05, 1396/01/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-05, 1396/01/16
Registrant information
Name
Hosein Hemmati
Name of organization / entity
Vascular surgery and dialysis research center, Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 3354 2460
Email address
hemmati@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
state
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic Effects of Heparin on Treatment of chronic diabetic foot ulcers: a randomized blind controlled clinical trial
Public title
Heparin Effect on Diabetic Foot Ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria
1- Recent chronic neuropathic diabetic foot ulcer (less than 10 days)
2- Ulcer Wagner grade is 1 or debrided patients or limited amputation with Wagner grade of 2, 3, and 4
3- ABI > 0.9 (not ischemic and neuroischemic)
4- Open or debrided ulcer or limited amputation
5- Having informed consent for study inclusion
Exclusion Criteria
1- Chronic diabetic foot ulcers caused by ischemia
2- Under treatment with anticoagulant therapy at the time of study inclusion
3- contraindication of low molecular weight heparin administration, including severe renal failure (creatinine lower than 30 ml/min (hepatic failure of Child-Pugh class B or C, having bleeding disorders and proliferative diabetic retinopathy subject to bleeding risk
4- Active osteomyelitis
5- Systemic sepsis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random Numbers Table produced by computer
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
GUMS Research and Technology Deputy building
City
Rasht
Postal code
Approval date
2016-11-08, 1395/08/18
Ethics committee reference number
IR.GUMS.REC.1395.265
Health conditions studied
1
Description of health condition studied
Chronic Diabetic Foot Ulcer
ICD-10 code
E 10.6
ICD-10 code description
Insulin-dependent diabetes mellitus with other specified complications
Primary outcomes
1
Description
Diabetic Foot Ulcer
Timepoint
every 10 days in 30-day period
Method of measurement
Digital imaging
Secondary outcomes
empty
Intervention groups
1
Description
Study group: Daily injection of 40 mg of low-molecular weight heparin during 30 days
Category
Treatment - Drugs
2
Description
Control group: Daily injection of 0.2 ml of normal saline during 30 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht Razi Hospital
Full name of responsible person
Dr. Milad Sarrafi
Street address
Razi Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Street address
Guilan University of Medical Sciences
City
Rasht
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr Milad Sarrafi
Position
Physician
Other areas of specialty/work
Street address
Razi Hospital
City
Rasht
Postal code
Phone
00
Fax
Email
Miladsarafi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Hossein Hemmati
Position
Associate Professor - Fellowship in Vascular Surgery
Other areas of specialty/work
Street address
Razi Hospital
City
Rasht
Postal code
Phone
00
Fax
Email
hemmati@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Hossein Hemmati
Position
Associate Professor - Fellowship in Vascular Surgery
Other areas of specialty/work
Street address
Razi Hospital
City
Rasht
Postal code
Phone
00
Fax
Email
hemmati@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)