Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

June 4, 2010 updated by: Universidad Complutense de Madrid

Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Hypothesis:Surgical treatment of osteomyelitis in diabetic foot is more effective that medical treatment through antibiotherapy and leads wound healing in ulcers complicated with bone infection.Material and Methods: Randomized clinical trials which include two groups of patients (n=88), one receives medical treatment through antibiotherapy during 90 days and the other group receive conservative surgical treatment and antibiotics during 7 days after surgery. It will be studied differences between both groups in healing time, recidives, present and relationship of adverse events and outflow of quality of life related health .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • José Luis Lázaro Martínez
        • Contact:
        • Sub-Investigator:
          • Esther Alicia García Morales, PhD
        • Sub-Investigator:
          • Silvia Allas Aguado, DP
        • Sub-Investigator:
          • Máximo Antonio González Jurado, RN, DP, PhD
        • Sub-Investigator:
          • Gabriel Rivera San Martín, DP
        • Sub-Investigator:
          • María del Carmen García Carrión, MD, PhD
        • Sub-Investigator:
          • Juan Vicente Beneit Montesinos, MD,PhD
        • Principal Investigator:
          • Franciso Javier Aragón Sánchez, MD, PhD
        • Sub-Investigator:
          • Almudena Cecilia Matilla, DP
        • Sub-Investigator:
          • Yolanda García Álvarez, RN, DP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Diabetes Mellitus Type 1 or 2.
  • Patients with diabetic foot ulcers.
  • Patients with clinical suspects of osteomyelitis.
  • Patients with positive probe to bone test.
  • Patients with signs of osteolysis in the bone located adjacent to the ulcer in X-Ray
  • Patients with transcutaneous oxygen oxygenation above 30 mmHg.
  • Acceptance to participate in the study through prior informed consent.

Exclusion Criteria:

  • Patients with osteomyelitis associated with necrotizing soft tissue infections.
  • Presence of necrotic tissue in the wound bed, edges or margins of the lesion.
  • HbAc1 > 10.
  • Presence of systemic toxicity such as fever, tachycardia, confusion, disorientation, vomiting or other signs usually related to systemic infection.
  • Patients with bone exposure through the ulcer.
  • Patients with absent pulses, ankle/brachial index (ABI) <0.8 and TcPO2 <30 mmHg.
  • Pregnancy.
  • Allergies to antibiotics.
  • Any degree of renal impairment that contraindicated the administration of antibiotics proposed.
  • Hepatic insufficiency.
  • Mental Illnesses that prevent the understanding by the patient's proposed treatment, or for any other reason associated with your mental health, to recommend their inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients undergoing medical treatment

Antibiotic treatment within 90 days with:

Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.
Drug: Ciprofloxacin
500 mg/ 12 hours during 90 days
Drug: Amoxicillin-Potassium Clavulanate Combination
875/125 mg/12 hours during 90 days
Drug: Sulfamethoxazole trimethoprim
Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.
Other: Patients undergoing surgical treatment
Conservative surgical Minor amputation 7 days antibiotic after surgical
Procedure: Conservative surgery
Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of healing patients
Time Frame: 12 weeks
Number of diabetic foot ulcers healing in both arms.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reulceration
Time Frame: 1 year after healing
Analysis of re-ulceration events in both arms after healing in a 1 year follow-up
1 year after healing
Healing time
Time Frame: 12 weeks
Healing time in both arms
12 weeks
Complications
Time Frame: 12 weeks
Percentage of complications in both arms
12 weeks
Quality of life
Time Frame: 12 weeks
Quality of life related to health in both arms
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: José Luis Lázaro Martínez, PhD, Universidad Complutense de Madrid
  • Study Chair: Francisco Javier Aragón Sánchez, MD, PhD, Hospital La Paloma Las Palmas de Gran Canaria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

June 4, 2010

First Submitted That Met QC Criteria

June 4, 2010

First Posted (Estimate)

June 7, 2010

Study Record Updates

Last Update Posted (Estimate)

June 7, 2010

Last Update Submitted That Met QC Criteria

June 4, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OM-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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