This is a double blind study, for assessing the effect of topical myrtle extract (6%) and placebo ( Gel base) in the treatment of diabetic foot ulcer. 20 diabetic patients with grade I or II, stage A foot ulcers (according to the Texas University Wound Classification System) voluntarily are enrolled. The patients are randomly divided to two groups of intervention and placebo by the random number table; standard treatment (dressing properly +control blood sugar + off-loading ) with local myrtle product, or standard treatment with placebo for 8 weeks. If necessary, surgical debridement of wounds will be performed at the first visit and at follow-up visits. Drug or placebo will be applied topically once daily. Wound sizes at the beginning and at the end of each week will be measured. Before entering the study, the required information is taken by the project agent and after receiving a written signed consent form and demographic questionnaire is filled. At the end of the study, relevant information is extracted and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022126684N1
Registration date:2016-07-31, 1395/05/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-31, 1395/05/10
Registrant information
Name
Seyed Ali Khodaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3728 0215
Email address
sa.khodaei@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahed University
Expected recruitment start date
2016-07-30, 1395/05/09
Expected recruitment end date
2016-11-29, 1395/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Topical Myrtus Communis Product on Diabetic Foot Ulcer; A Pilot Study
Public title
Effect of Myrtle on Diabetic Foot Ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age 18 years old and more; type 1 or 2 diabetes with glysemin control; have dorsalis pedis and posterior tibial pulses; ulcer size ≥ 1 cm2; grade IA or IIA according to Texas University Foot Wound Classification System.
Exclusion criteria: clinical infection at the studied ulcer site; clinically significant lower-extremity
ischemia (ABI< 0.65); nondiabetic ulcer; active Charcot’s disease; hypersensitivity to any drugs; pregnant or lacting woman; any sever disease that may impair wound healing (sever hepatic disease and cirrhosis, connective tissue diseases, malignancy, treatment with dialysis, vasculitis, immune system disorders); immunosuppressive agents; chemotherapy or radiation therapy; current abuse of alcohol or other substances; HbA1c>10%; serious psychological problems.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University
Street address
Opposite of Imam Khomeiny shrine, Tehran-Qom Freeway
City
Tehran
Postal code
Approval date
2016-02-22, 1394/12/03
Ethics committee reference number
IR.Shahed.REC.1394.97
Health conditions studied
1
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E14.5
ICD-10 code description
Unspecified diabetes mellitus with peripheral circulatory complications
Primary outcomes
1
Description
Wound surface area
Timepoint
weekly
Method of measurement
To determine this outcome, a ruler will be placed at the wound margin and then digital photograph will be taken and the wound surface area will be determined using special software through planimetry methods
Secondary outcomes
1
Description
Clinical assessment of advers event
Timepoint
weekly
Method of measurement
Adverse Event Report Form
Intervention groups
1
Description
Treatment of diabetic foot ulcers with myrtle product(6%) topically once daily for 8 weeks
Category
Treatment - Drugs
2
Description
Treatment of diabetic foot ulcers with placebo(base gel) topically, once daily for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic and Metabolic Center of Tehran affiliated to Endocrinology and Metabolism Research Center
Full name of responsible person
Seyed Ali Khodaie
Street address
5th Floor, Shariati Hospital, North Karegar street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahed University
Full name of responsible person
Dr. Mohsen Naseri
Street address
No.1471, Between Forsat and Nosrat St, North Kargar Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahed University
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
Shahed University
Full name of responsible person
Seyed Ali Khodaie
Position
MD
Other areas of specialty/work
Street address
No.1471, Between Forsat and Nosrat St, North Kargar Ave
City
Tehran
Postal code
Phone
+98 21 5121 4056
Fax
Email
dr.seyedalikhodaie@yahoo.com; salikhd@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Position
MD, PhD
Other areas of specialty/work
Street address
No.1471, Between Forsat and Nosrat St, North Kargar Ave
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
naseri@shahed.ac.ir; naserishahed@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Seyed Ali Khodaie
Position
MD
Other areas of specialty/work
Street address
No.1471, Between Forsat and Nosrat St, North Kargar Ave
City
Tehran
Postal code
Phone
Fax
Email
dr.seyedalikhodaie@yahoo.com; salikhd@yahoo.com;
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)