Osteomyelitis, Diabetic Foot, Diabetic Foot Ulcers
Conditions
Keywords
Diabetic foot, Osteomyelitis, Diabetic foot ulcers, Foot infections
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 .
Interventions
PROCEDUREConservative surgery
Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy
DRUGCiprofloxacin
500 mg/ 12 hours during 90 days
875/125 mg/12 hours during 90 days
Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of healing patients | 12 weeks | Number of diabetic foot ulcers healing in both arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reulceration | 1 year after healing | Analysis of re-ulceration events in both arms after healing in a 1 year follow-up |
| Healing time | 12 weeks | Healing time in both arms |
| Complications | 12 weeks | Percentage of complications in both arms |
| Quality of life | 12 weeks | Quality of life related to health in both arms |
Countries
Spain
Contacts
Primary ContactJosé Luis Lázaro Martínez, PhD
Outcome results
None listed