Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Sponsor

Universidad Complutense de Madrid (Other)

Overall Status

Unknown status

CT.gov ID

NCT01137903

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Osteomyelitis Diabetic Foot Diabetic Foot Ulcers	Procedure: Conservative surgery Drug: Ciprofloxacin Drug: Amoxicillin-Potassium Clavulanate Combination Drug: Sulfamethoxazole trimethoprim	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Apr 1, 2011

Anticipated Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients undergoing medical treatment Antibiotic treatment within 90 days with: Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.	Drug: Ciprofloxacin 500 mg/ 12 hours during 90 days Drug: Amoxicillin-Potassium Clavulanate Combination 875/125 mg/12 hours during 90 days Drug: Sulfamethoxazole trimethoprim Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.
Other: Patients undergoing surgical treatment Conservative surgical Minor amputation 7 days antibiotic after surgical	Procedure: Conservative surgery Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy

Arm

Intervention/Treatment

Other: Patients undergoing medical treatment

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

Drug: Ciprofloxacin

500 mg/ 12 hours during 90 days

Drug: Amoxicillin-Potassium Clavulanate Combination

875/125 mg/12 hours during 90 days

Drug: Sulfamethoxazole trimethoprim

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

Other: Patients undergoing surgical treatment

Conservative surgical Minor amputation 7 days antibiotic after surgical

Procedure: Conservative surgery

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

Outcome Measures

Primary Outcome Measures

Number of healing patients [12 weeks]
Number of diabetic foot ulcers healing in both arms.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	José Luis Lázaro Martínez	Madrid		Spain	28040

Sponsors and Collaborators

Universidad Complutense de Madrid

Investigators

Principal Investigator: José Luis Lázaro Martínez, PhD, Universidad Complutense de Madrid
Study Chair: Francisco Javier Aragón Sánchez, MD, PhD, Hospital La Paloma Las Palmas de Gran Canaria