Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01137903
• Other study ID #: OM-2010
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2010
• Last updated: June 4, 2010
• Start date: April 2010
• Est. completion date: November 2011

Study information

• Verified date: May 2010
• Source: Universidad Complutense de Madrid
• Contact: José Luis Lázaro Martínez, PhD
• Phone: +34913942203
• Email: diabetes[@]enf.ucm.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: November 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Osteomyelitis
• Ulcer

Intervention

Procedure:
• Conservative surgery
Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy

Drug:
• Ciprofloxacin
500 mg/ 12 hours during 90 days
• Amoxicillin-Potassium Clavulanate Combination
875/125 mg/12 hours during 90 days
• Sulfamethoxazole trimethoprim
Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.

Locations

Country	Name	City	State
Spain	José Luis Lázaro Martínez	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of healing patients	Number of diabetic foot ulcers healing in both arms.	12 weeks	No
Secondary	Reulceration	Analysis of re-ulceration events in both arms after healing in a 1 year follow-up	1 year after healing	No
Secondary	Healing time	Healing time in both arms	12 weeks	No
Secondary	Complications	Percentage of complications in both arms	12 weeks	No
Secondary	Quality of life	Quality of life related to health in both arms	12 weeks	No