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Comparison Efficiency of Six-Weeks Versus Twelve-Weeks Administration of Clindamycin and Ciprofloxacin in Treatment of Diabetic Foot Osteomyelitis Without Surgical Indication

Protocol summary

Summary
(1) Objectives: Comparison efficiency of six-weeks versus twelve-weeks administration of clindamycin and ciprofloxacin in treatment of diabetic foot osteomyelitis without surgical indication based on the size of the wound, some biochemical and hematology parameters, bone probe test, culture of wound secretion, age and gender of patients, common aerobic bacterial causes of osteomyelitis and determine the antibiotic resistance of common bacterial causes of osteomyelitis in the studied population. (2) Design: The study will be intervention (experimental), including 30 patients with diabetic foot osteomyelitis without surgical indication consulted to diabetes clinic of Imam Khomeini hospital and hospitalized cases in the internal sector of there. (3) Setting and conduct: samples will be equally divided into the 6 and 12 weeks of treatment with antibiotics (ciprofloxacin + clindamycin) groups. All of the obtained variables will be classified according to the recovery or non-recovery status of patients. (4) Participants including major eligibility criteria: including criteria: confirmation of osteomyelitis in patients with diabetic foot; the absence of obesity, chronic systemic diseases and drug resistance to ciprofloxacin and clindamycin, and exclusion criteria included: the need surgical intervention at any time of the study, the presence of any of the disorders during the study follow-up and treatment of diseases, resistance of the causes against to the used antibiotics, lack of anterior and posterior leg pulses, and pregnancy. (5) Intervention: The intervention will be done when 6 or 12 weeks. (6) Main outcome measures (variables): they will be lower ESR and leukocytosis, and wound healing.

General information

Acronym
DFO
IRCT registration information
IRCT registration number: IRCT2016110830793N1
Registration date: 2017-04-08, 1396/01/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-08, 1396/01/19
Registrant information
Name
Elnaz Afrozeh
Name of organization / entity
Ardabil Medical University
Country
Iran (Islamic Republic of)
Phone
+98 41 3381 2998
Email address
e.afrozeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr. Shahram Habib Zadeh, Vice Chancellor for Research, Ardabil University of Medical Sciences. Address: End of University Avenue, Office Complex Medical University, Vice Chancellor for Research, Ardabil University of Medical Sciences, Ardabil, Tel: 00984533522089, Email: research@arums.ac.ir.
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Efficiency of Six-Weeks Versus Twelve-Weeks Administration of Clindamycin and Ciprofloxacin in Treatment of Diabetic Foot Osteomyelitis Without Surgical Indication
Public title
Efficiency of Clindamycin and Ciprofloxacin in Treatment of Diabetic Foot Osteomyelitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion main criteria: confirmed the diagnosis of osteomyelitis with no surgery in patients with diabetic foot; absence of chronic liver, renal, coronary arteries, anemia, rheumatism,...; absence of resistance against ciprofloxacin and clindamycin; no recent use of ciprofloxacin and clindamycin; absence of marked obesity (BMI more than 30) Exclusion main criteria: surgical intervention at any time of the study; any disorder factors during the study follow-up and treatment; absence of etiologic agents resistance against the used antibiotics; absence of posterior and anterior pulse (by arterial Doppler test); pregnancy and absence of drug gastrointestinal complications; existence of drug complication against ciprofloxacin and clindamycin during the study; resistance against ciprofloxacin and clindamycin.
Age
From 30 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
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
Ethics committee of Ardabil medical university
Street address
End of University Avenue, Office Complex Ardabil Medical University, Ardabil, Postal Code: 85991-56189, Tel: 0984553522247-53.
City
Ardabil
Postal code
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
IR-ARUMS-REC-1395-54

Health conditions studied

1

Description of health condition studied
ِDiabetic foot osteomyelitis
ICD-10 code
M86.8
ICD-10 code description
Other osteomyelitis

Primary outcomes

1

Description
radiography
Timepoint
At the begining and end of the study
Method of measurement
Inflammation and air in the soft tissue, cortical bone destruction, irregular margins of skin at the wound site and in chronic cases of cortical erosions-reaction Periosteal, sclerosis and squestra.

2

Description
Hb A1c
Timepoint
At the begining and end of the study
Method of measurement
%, chromatography

3

Description
ESR
Timepoint
At the begining and every two weeks until the end of the study
Method of measurement
mm/hr, ESR reader

4

Description
positive probing test
Timepoint
At the begining of the study
Method of measurement
Touch or contact with prob

5

Description
FBS
Timepoint
at least 8 hrs fasting then at the begining and every two weeks until the end of the study
Method of measurement
mg/dl, autoanalyser

6

Description
2h pp Glu
Timepoint
at 2 hrs after glucose administration at the begining and every two weeks until the end of the study
Method of measurement
mg/dl, autoanalyser

7

Description
creatinine
Timepoint
at the begining and end of the study
Method of measurement
mg/dl, autoanalyser

8

Description
albumin
Timepoint
at the begining and every two weeks until the end of the study
Method of measurement
g/dl, autoanalyser

9

Description
the surface and depth measure of the ulcer
Timepoint
at the begining and end of the study
Method of measurement
mm2

10

Description
microbial culture and antibiogram
Timepoint
at the begining of the study
Method of measurement
S or R, culture in microbial media and biochemical test

11

Description
Blood cell count
Timepoint
at the begining and every two weeks until the end of the study
Method of measurement
*10 9 /L, hematology cell counter

12

Description
WBC diff count
Timepoint
at the begining and every two weeks until the end of the study
Method of measurement
*10 9 /L, hematology cell counter

13

Description
CRP
Timepoint
at the begining and every two weeks until the end of the study
Method of measurement
mg/dl, Nycocard

14

Description
RBC indices: MCV, MCH, MCHC
Timepoint
at the begining and every two weeks until the end of the study
Method of measurement
fl, pg, %, Hematology cell counter

15

Description
BMI
Timepoint
at the begining of the study
Method of measurement
kg/m2, determination based weight/height2

Secondary outcomes

empty

Intervention groups

1

Description
Tab. ciprofloxacin 500 mg, PO, BD, 6 weeks Cap. clindamycin 300 mg, PO, TDS, 6 weeks
Category
Treatment - Drugs

2

Description
Tab. ciprofloxacin 500 mg, PO, BD, 12 weeks Cap. clindamycin 300 mg, PO, TDS, 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Ardabil Imam Khomeini Hospital
Full name of responsible person
Mahnaz Ghannadi Asl
Street address
Ardabil Imam Khomeini Hospital, Ataei St., Ardabil.
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Ardabil University of Medical Sciences
Full name of responsible person
Dr.Shahram Habib Zadeh
Street address
End of University Avenue, Office Complex Medical University, Vice Chancellor for Research, Ardabil University of Medical Sciences, Ardabil
City
Ardabil
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, Ardabil 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
Ardabil Medical University
Full name of responsible person
Elnaz Afrozeh
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Internal Sector of Imam Khomeini Hospital, َArdabil Imam Khomeini Hospital, Ataei St, Ardabil
City
Ardabil
Postal code
Phone
+98 45 3325 1401
Fax
Email
e.afrozeh@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil Medical University
Full name of responsible person
Manouchehr Iranparvar
Position
Professor of Endocrine and Metaboilc Disease
Other areas of specialty/work
Street address
Internal Sector of Imam Khomeini Hospital, Ardabil Imam Khomeini Hospital, Ataei St, Ardabil
City
Ardabil
Postal code
Phone
+98 45 3325 1401
Fax
Email
eshratkhah.behrad@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
I.A.U. of Shabestar Branch
Full name of responsible person
Behrad Eshratkhah
Position
PhD,Clinial Pathology
Other areas of specialty/work
Street address
I.A.U. of Shabestar Branch, Azadegan St., Shabestar
City
Tabriz
Postal code
5381637181
Phone
+98 41424253125
Fax
Email
eshratkhah.behrad@gmail.com; beshratkhah@iaushab.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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