Determination of therapeutic effect of Teucrium polium extract on healing process of diabetic foot, compared to placebo.
Design
Sixty type 1 and type 2 diabetic patients with 1st or 2nd degree foot ulcers in the Wagner scale is selected from diabetic clinic. Patients are randomly divided into two arm parallel groups according to block randomization. This phase 2-3 clinical trial is multi center, double blind and placebo controlled study.
Settings and conduct
This study will be carried out in Diabetic Clinic of Emam Reza Hospital in Mashhad University of Medical Sciences.
The patients receive twice daily dressings of Teucrium polium or placebo ointment. The medical staff and the patients are not aware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: type 1 or 2 diabetic patients with 1st or 2nd degree foot ulcer according to Brachial Ankle Index test; 20 to 60 years old patients;
Exclusion criteria: uncontrolled diabetic patients with progressed diabetic foot ulcers; diabetic foot ulcer candidate for amputation; disabled patients; patients with renal failure (creatinine clearance above 2); patients under therapy with glucocorticoids; smoker and addict patients; patients with BMI greater than 25; patients suffering from vascular disorder and chronic diseases.
Intervention groups
Teucrium polium group: The patients in this group, in addition to common medications for diabetic foot ulcer healing, receive twice daily dressings of Teucrium polium ointment.
Placebo group: The patients in this group, in addition to common medications for diabetic foot ulcer healing, receive twice daily dressings of Placebo ointment.
Main outcome variables
Diabetic foot ulcer healing; restoration time; surface temperature around the wound.
General information
Reason for update
Acronym
interventional
IRCT registration information
IRCT registration number:IRCT20170821035817N2
Registration date:2018-03-26, 1397/01/06
Registration timing:prospective
Last update:2018-03-26, 1397/01/06
Update count:0
Registration date
2018-03-26, 1397/01/06
Registrant information
Name
Maryam Yaghoubi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2077
Email address
yaghoubim6@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences Research Deputy -Research Institute of Medicinal Plants of Alborz University
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-03-05, 1397/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Teucrium polium on diabetic foot ulcer
Public title
Effects of Teucrium polium on dibetic ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 1 or 2 diabetic patients suffering with 1st or 2nd degree foot ulcer
20 to 60 years old patients
No vascular diseases
No suffering from other chronic diseases
Exclusion criteria:
Patients with progressed diabetic foot ulcers
Patients with diabetic foot ulcer candidate for amputation
Disabled patients
Patients with renal failure (creatinine clearance above 2)
Patients treated with glucocorticoids
Smoker and addict patients
Patients with BMI greater than 25
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The enrolled patients were randomly assigned into 2 groups according to randomized block design.
To select patients, each of them is given number 1 to 60 (total sample size) according to their referral time.
Then patients according to their numbers, randomly receives the ointment A or B.
Teucrium polium and placebo ointment are filled in identical tube and labeled as ointment A or ointment B.
Only principal investigator knows the content of the ointment labeled A or B.
Blinding (investigator's opinion)
Double blinded
Blinding description
On identical tubes containing the Teucrium polium and placebo, the ointment A and ointment B are labeled.
Other specifications on the labels are identical.
Physician, patient, data collector and analyzer are unaware of the nature and meaning of the letters A and B on the label.
Only the principal researcher knows the meaning of the letters A and B on the label.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences.
Street address
Emam Reza hospital, Daneshgah Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2017-07-30, 1396/05/08
Ethics committee reference number
IR.MUMS.REC.1396.143
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
ٍE10, E11
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Healing up of diabetic foot ulcer
Timepoint
1 month
Method of measurement
Ulcer digital photography; microbial ulcer tissue culture
Secondary outcomes
1
Description
Ulcer temperature
Timepoint
1 month
Method of measurement
Digital thermometer
Intervention groups
1
Description
Intervention : Teucrium polium ointment dressing apply on ulcer two times a day
Category
Treatment - Drugs
2
Description
Control: Placebo ointment dressing apply on ulcer two times a day