Diabetes is an increasing health problem in the modern countries. Diabetic foot develops in about 20% of diabetic patients which can decrease their quality of life. This clinical trial study was conducted to evaluate the effect of Beneh ointment on the improvement of diabetic foot in out-patient and in-patient diabetic patients referred to Beheshti hospital. The inclusion criterion is strict evidence of diabetic (2 times: FBS >126 mg/dl) and clinical findings suggestive of infection of wound (erythematic, swelling, discharge). The patients are categorized in two groups. In one group only systemic antibiotic and in the second group the systemic antibiotic plus Beneh ointment are used. Clinical improvement of the wound and negative result of the wound culture are the main criterion for the effectiveness of Beneh ointment .The results of the study were analyzed by SPSS (version 14) using K square.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812243576N1
Registration date:2010-09-30, 1389/07/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-30, 1389/07/08
Registrant information
Name
Zahra Soleimani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0030
Email address
soleimani.zahra@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
kashan university of medical science
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-06-22, 1389/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Pistachio (mutica or atlantica) in improvement of diabetic foot
Public title
Evaluation of the effectiveness of Pistachio (mutica or atlantica) in improvement of diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Patients have with definitive diabetic and lower limb infective ulcer
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
kashan university of medical science
Street address
Kashan-ghotberavandi Boulvard
City
Kashan
Postal code
8715988141
Approval date
empty
Ethics committee reference number
4948/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Diabetic foot
ICD-10 code
E14.5
ICD-10 code description
With peripheral circulatory complication:diabetic ulcer
Primary outcomes
1
Description
depth of ulcer
Timepoint
7 days
Method of measurement
infectious disease specialist with a ruller
2
Description
tempreture at ulcer bed
Timepoint
7 days
Method of measurement
infectious disease specialist with termometer
3
Description
diameter of ulcer
Timepoint
7 days
Method of measurement
the wounds shape is transferred on to a checkered using a nylon
Secondary outcomes
1
Description
Number of days till recovery
Timepoint
7 days
Method of measurement
infectious specialist, counting the days after treatment started
2
Description
infection complication
Timepoint
7 days
Method of measurement
infectious specialist, culture of wound secretions
Intervention groups
1
Description
In interventional group, Beneh ointment and systemic antibiotic are used. Topical ointment is derived from Pistachio plant. It consist of 50% Pistachio, 30% lanoline, 20% ucerine. It applied as a tine layer on the surface of the wound (once daily, at least 1 week). Systemic antibiotic consist of: Cloxacillin Amp 1 g q6h, Ceftriaxone Amp 1 g q12h, Clindamycin Amp 600 mg q6h(at least: 7 days)
Category
Treatment - Drugs
2
Description
In control group used only systemic antibiotic: Cloxacillin Amp 1 g q6h, Ceftriaxone Amp 1 g q12h, Clindamycin Amp 600 mg q6h (at least: 7 days)