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Efficiency of Clindamycin and Ciprofloxacin in Treatment of Diabetic Foot Osteomyelitis

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016110830793N1
Enrollment
30
Registered
2017-04-08
Start date
2016-05-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

?Diabetic foot osteomyelitis. Other osteomyelitis

Interventions

Intervention 1: Tab. ciprofloxacin 500 mg, PO, BD, 6 weeks Cap. clindamycin 300 mg, PO, TDS, 6 weeks. Intervention 2: Tab. ciprofloxacin 500 mg, PO, BD, 12 weeks Cap. clindamycin 300 mg, PO, TDS, 12 w
Treatment - Drugs
Tab. ciprofloxacin 500 mg, PO, BD, 6 weeks Cap. clindamycin 300 mg, PO, TDS, 6 weeks
Tab. ciprofloxacin 500 mg, PO, BD, 12 weeks Cap. clindamycin 300 mg, PO, TDS, 12 weeks

Sponsors

Vice Chancellor for Research, Ardabil University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 45 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.;Hb A1c. Timepoint: At the begining and end of the study. Method of measurement: %, chromatography.;ESR. Timepoint: At the begining and every two weeks until the end of the study. Method of measurement: mm/hr, ESR reader.;Positive probing test. Timepoint: At the begining of the study. Method of measurement: Touch or contact with prob.;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.;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.;Creatinine. Timepoint: at the begining and end of the study. Method of measurement: mg/dl, autoanalyser.;Albumin. Timepoint: at the begining and every two weeks until the end of the study. Method of measurement: g/dl, autoanalyser.;The surface and depth measure of the ulcer. Timepoint: at the begining and end of the study. Method of measurement: mm2.;Microbial culture and antibiogram. Timepoint: at the begining of the study. Method of measurement: S or R, culture in microbial media and biochemical test.;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.;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.;CRP. Timepoint: at the begining and every two weeks until the end of the study. Method of measurement: mg/dl, Nycocard.;RBC indices: MCV, MCH, MCHC. Timepoint: at the begining and every two weeks until the end of the study. Method of measurement: fl,

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElnaz Afrozeh

Ardabil Medical University

e.afrozeh@arums.ac.ir+98 45 3325 1401

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026