Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

NCT01137903 | Unknown DMC

• 1 other identifier: OM-2010
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Osteomyelitis; Diabetic Foot; Diabetic Foot Ulcers

Keywords

Diabetic foot; Osteomyelitis; Diabetic foot ulcers; Foot infections

Outcome Measures

Primary Outcomes (1)

• Number of healing patients

  Number of diabetic foot ulcers healing in both arms.

  12 weeks

Secondary Outcomes (4)

• Reulceration

  1 year after healing

• Healing time

  12 weeks

• Complications

  12 weeks

• Quality of life

  12 weeks

Study Arms (2)

Patients undergoing medical treatment

OTHER

Antibiotic treatment within 90 days with: Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.

Drug: Ciprofloxacin; Drug: Amoxicillin-Potassium Clavulanate Combination; Drug: Sulfamethoxazole trimethoprim

Patients undergoing surgical treatment

OTHER

Conservative surgical Minor amputation 7 days antibiotic after surgical

Procedure: Conservative surgery

Interventions

Conservative surgery PROCEDURE

Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy

Patients undergoing surgical treatment

Ciprofloxacin DRUG

500 mg/ 12 hours during 90 days

Patients undergoing medical treatment

Amoxicillin-Potassium Clavulanate Combination DRUG

875/125 mg/12 hours during 90 days

Patients undergoing medical treatment

Sulfamethoxazole trimethoprim DRUG

Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.

Patients undergoing medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

José Luis Lázaro Martínez

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (1)

• Lazaro-Martinez JL, Aragon-Sanchez J, Garcia-Morales E. Antibiotics versus conservative surgery for treating diabetic foot osteomyelitis: a randomized comparative trial. Diabetes Care. 2014;37(3):789-95. doi: 10.2337/dc13-1526. Epub 2013 Oct 15.

  PMID: 24130347 DERIVED

MeSH Terms

Conditions

Osteomyelitis; Diabetic Foot

Interventions

Ciprofloxacin; Amoxicillin-Potassium Clavulanate Combination; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Drug Combinations; Pharmaceutical Preparations; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• José Luis Lázaro Martínez, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

• Francisco Javier Aragón Sánchez, MD, PhD

  Hospital La Paloma Las Palmas de Gran Canaria

  STUDY CHAIR

Central Study Contacts

José Luis Lázaro Martínez, PhD

CONTACT

+34913942203; diabetes@enf.ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 7, 2010

Record last verified: 2010-05

Locations

ES (1)