Clinical trial NCT01137903: Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers
Official title: Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteomyelitis
Diabetic Foot
Diabetic Foot Ulcers
Keywords: Diabetic foot
Osteomyelitis
Diabetic foot ulcers
Foot infections
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2010-06-07
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 .


Eligibility 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.

Primary outcomes:
measure: Number of healing patients
timeFrame: 12 weeks
Secondary outcomes:
measure: Reulceration
timeFrame: 1 year after healing
measure: Healing time
timeFrame: 12 weeks
measure: Complications
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: José Luis Lázaro Martínez
Study officials:
affiliation: Universidad Complutense de Madrid
name: José Luis Lázaro Martínez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital La Paloma Las Palmas de Gran Canaria
name: Francisco Javier Aragón Sánchez, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.