Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Condition(s) targeted: Osteomyelitis; Diabetic Foot; Diabetic Foot Ulcers

Intervention: Conservative surgery (Procedure); Ciprofloxacin (Drug); Amoxicillin-Potassium Clavulanate Combination (Drug); Sulfamethoxazole trimethoprim (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Universidad Complutense de Madrid

Official(s) and/or principal investigator(s):
José Luis Lázaro Martínez, PhD, Principal Investigator, Affiliation: Universidad Complutense de Madrid
Francisco Javier Aragón Sánchez, MD, PhD, Study Chair, Affiliation: Hospital La Paloma Las Palmas de Gran Canaria

Overall contact:
José Luis Lázaro Martínez, PhD, Phone: +34913942203, Email: diabetes@enf.ucm.es

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 .

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

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

Primary outcome: Number of healing patients

Secondary outcome:

Reulceration

Healing time

Complications

Quality of life

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

José Luis Lázaro Martínez, PhD, Phone: +34913942203, Email: diabetes@enf.ucm.es

José Luis Lázaro Martínez, Madrid 28040, Spain; Recruiting
José Luis Lázaro Martínez, PhD, Phone: +34913942203, Email: diabetes@enf.ucm.es
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, Sub-Investigator
José Luis Lázaro Martínez, PhD, Principal Investigator
Franciso Javier Aragón Sánchez, MD, PhD, Principal Investigator
Almudena Cecilia Matilla, DP, Sub-Investigator
Yolanda García Álvarez, RN, DP, Sub-Investigator

Starting date: April 2010
Last updated: June 4, 2010