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Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Primary Purpose

Osteomyelitis, Diabetic Foot, Diabetic Foot Ulcers

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Conservative surgery

Ciprofloxacin

Amoxicillin-Potassium Clavulanate Combination

Sulfamethoxazole trimethoprim

About this trial

This is an interventional treatment trial for Osteomyelitis focused on measuring Diabetic foot, Osteomyelitis, Diabetic foot ulcers, Foot infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

José Luis Lázaro MartínezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Patients undergoing medical treatment

Patients undergoing surgical treatment

Arm Description

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

Conservative surgical Minor amputation 7 days antibiotic after surgical

Outcomes

Primary Outcome Measures

Number of healing patients

Number of diabetic foot ulcers healing in both arms.

Secondary Outcome Measures

Reulceration

Analysis of re-ulceration events in both arms after healing in a 1 year follow-up

Healing time

Healing time in both arms

Complications

Percentage of complications in both arms

Quality of life

Quality of life related to health in both arms

Full Information

NCT ID

NCT01137903

First Posted

June 4, 2010

Last Updated

June 4, 2010

Sponsor

Universidad Complutense de Madrid

1. Study Identification

Unique Protocol Identification Number

NCT01137903

Brief Title

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

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

April 2010 (undefined)

Primary Completion Date

April 2011 (Anticipated)

Study Completion Date

November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Universidad Complutense de Madrid

4. Oversight

Data Monitoring Committee

Yes

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteomyelitis, Diabetic Foot, Diabetic Foot Ulcers

Keywords

Diabetic foot, Osteomyelitis, Diabetic foot ulcers, Foot infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients undergoing medical treatment

Arm Type

Other

Arm Description

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

Arm Title

Patients undergoing surgical treatment

Arm Type

Other

Arm Description

Conservative surgical Minor amputation 7 days antibiotic after surgical

Intervention Type

Procedure

Intervention Name(s)

Conservative surgery

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin

Intervention Description

500 mg/ 12 hours during 90 days

Intervention Type

Drug

Intervention Name(s)

Amoxicillin-Potassium Clavulanate Combination

Intervention Description

875/125 mg/12 hours during 90 days

Intervention Type

Drug

Intervention Name(s)

Sulfamethoxazole trimethoprim

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of healing patients

Description

Number of diabetic foot ulcers healing in both arms.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Reulceration

Description

Analysis of re-ulceration events in both arms after healing in a 1 year follow-up

Time Frame

1 year after healing

Title

Healing time

Description

Healing time in both arms

Time Frame

12 weeks

Title

Complications

Description

Percentage of complications in both arms

Time Frame

12 weeks

Title

Quality of life

Description

Quality of life related to health in both arms

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

José Luis Lázaro Martínez, PhD

Phone

+34913942203

diabetes@enf.ucm.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José Luis Lázaro Martínez, PhD

Organizational Affiliation

Universidad Complutense de Madrid

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Francisco Javier Aragón Sánchez, MD, PhD

Organizational Affiliation

Hospital La Paloma Las Palmas de Gran Canaria

Official's Role

Study Chair

Facility Information:

Facility Name

José Luis Lázaro Martínez

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Luis Lázaro Martínez, PhD

Phone

+34913942203

diabetes@enf.ucm.es

First Name & Middle Initial & Last Name & Degree

Esther Alicia García Morales, PhD

First Name & Middle Initial & Last Name & Degree

Silvia Allas Aguado, DP

First Name & Middle Initial & Last Name & Degree

Máximo Antonio González Jurado, RN, DP, PhD

First Name & Middle Initial & Last Name & Degree

Gabriel Rivera San Martín, DP

First Name & Middle Initial & Last Name & Degree

María del Carmen García Carrión, MD, PhD

First Name & Middle Initial & Last Name & Degree

Juan Vicente Beneit Montesinos, MD,PhD

First Name & Middle Initial & Last Name & Degree

José Luis Lázaro Martínez, PhD

First Name & Middle Initial & Last Name & Degree

Franciso Javier Aragón Sánchez, MD, PhD

First Name & Middle Initial & Last Name & Degree

Almudena Cecilia Matilla, DP

First Name & Middle Initial & Last Name & Degree

Yolanda García Álvarez, RN, DP

12. IPD Sharing Statement

Citations:

PubMed Identifier

24130347

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.

Results Reference

derived

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Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

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