The aim of this study is to assess the efficacy of Oxytetracycline spray for the treatment of diabetic foot ulcers. in this randomized clinical trial, a total of 60 participants (enrolled into two groups) were recruited from a tertiary clinic in Mashhad(Emam-Reza Hospital). The patients aged between 43 and 85 years and were diagnosed with grade II foot ulcer based on the Wagner wound classification. Patients were excluded from the study if had severe perfusion dysfunction or severe kidney dysfunction. Control group received just standard wound care for diabetic foot ulcers and Intervention group received Oxytetracycline in addition of standard wound care. The wound surface area is determined as the primary outcome. Photographs will be taken of each diabetic foot at the beginning and at the end of research period for the purpose of comparison. Patients were followed for 1 month weekly and compared in term of rate of healing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112208472N1
Registration date:2012-06-10, 1391/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-10, 1391/03/21
Registrant information
Name
Gholam hossein Kazemzadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5311
Email address
kazemzadehgh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-12-26, 1390/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Oxytetracycline Spray in treatment of diabetic foot ulcers
Public title
Evaluation of the effect of Oxytetracycline spray in treatment of diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Presence of diabetes mellitus type 1 or 2; presence of ulcer on foot Extremities( grade II foot ulcer based on the Wagner wound classification); sutured ulcers with infection possibility; reconstruction dysfunction.
Exclusion criteria: patients not willing to voluntary cooperation; patients not willing for treatment; severe perfusion dysfunction(ABI<0.05); severe kidney dysfunction (Cr>2.5)
Age
From 43 years old to 85 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
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
Mashhad University of Medical Sciences
Street address
Ghoreishi`s Building, Daneshgah St
City
Mashhad
Postal code
91375-345
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
88026
Health conditions studied
1
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E10.5
ICD-10 code description
Insulin-dependent diabetes mellitus With peripheral circulatory complications
2
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E11.5
ICD-10 code description
Non-insulin-dependent diabetes mellitus with peripheral circulatory complications
Primary outcomes
1
Description
Wound surface area
Timepoint
Baseline, after 1,2,3 and 4 weeks
Method of measurement
To determine this outcome, digital photograph will be taken(by Digital camera Dino – lite AM-413 ) and the wound surface area will be determined using special software (Hakim Software) through planimetry methods(〖cm〗^2
Secondary outcomes
1
Description
Wound healing
Timepoint
baseline,week 1.2.3 and 4
Method of measurement
Clinical evaluation of wound for erythema, swelling and pus discharge
Intervention groups
1
Description
Oxytetracycline spray (contains 4.2 gr Oxytetracycline Hydrochloride,420 mg Gentian Violet and 210 ml Excipients and Propellant qs) Spray two times a day from a distance of 15 -20 cm localy at ulcer area for 4 weeks in addition to standard wound care (glycemic control, debridement, dressing, offloading and infection control)
Category
Treatment - Drugs
2
Description
standard wound care for diabetic foot ulcer (glycemic control, debridement, dressing, offloading and infection control)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vascular & Endovascular Surgery Research Center, Department of Vascular Surgery, Imam Reza Hospital
Full name of responsible person
Dr.Gholam-Hossein Kazemzadeh,Assistant professor
Street address
Ebne Sina St, Emam Reza Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical sciences
Full name of responsible person
Mohsen Tafaghodi PharmD,PhD
Street address
Ghoreishi building, Daneshgah Str
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Science
Full name of responsible person
Emad Ebrahimi
Position
Medical Student
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1891 5540
Fax
Email
ebrahimie841@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Gholam-Hossein Kazemzadeh
Position
Vascular Surgeon
Other areas of specialty/work
Street address
Emam Reza Hospital of Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5311
Fax
Email
kazemzadehgh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Emad Ebrahimi
Position
Medical Student
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
+98 51 1891 5540
Fax
Email
ebrahimie841@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)