A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients

Not Applicable

Completed

• Conditions: Photo Antimicrobial Chemotherapy; Osteomyelitis; Diabetic Foot Infection
• Interventions: Other: Ciprofloxacin; Radiation: PDT

• Registration Number: NCT03380403
• Lead Sponsor: Faculdade de Medicina do ABC

Brief Summary

The feet of diabetic patients continue to be an important problem in medicine. In general, patients with diabetic foot have some sort of amputation, especially in underserved populations. It is clearly necessary to develop novel treatment strategies for this worldwide health problem. Photodynamic therapy (PDT) , is a low cost and highly effective alternative treatment concerning infections avoiding amputations in the diabetic foot.

Detailed Description

Patients with infected diabetic foot were grouped according to the Wagner system for classifying foot lesions. All patients presented Wagner Grade 3 classification, with osteomyelitis in one or more toes. The study included only patients who had circulatory viability.

For PDT treatment the fistula and/or ulcer was used as a gateway to the bone. The treated area (bones and fingers) was irrigated with a solution of phenothiazinium salts. After that, light irradiation was performed with optical fibers or led device above the wound. PDT treatment always in outpatients, once or twice a week.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2012-01-01
• Study Completion: 2012-01-01
• Study First Submitted: 2017-11-24
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-21
• Last Update Submitted: 2017-12-26
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• age > 18 years old
• diabetes
• diabetic foot
• Wagner grade III

Exclusion Criteria

• age < 18 years old
• non-diabetic
• Wagner IV and V
• ischemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Ciprofloxacin	Ciprofloxacin	Diabetic foot patients were treated on conventional way, using antibiotics and surgery.
PDT	PDT	Methylene blue and Photon Irradiation , every each week, until total ulcer healing.

Primary Outcome Measures

Name	Time	Method
Infection control	every month until three months , when blood count- leucocytes reach the standard value.	blood count - leucocytes for infection

Secondary Outcome Measures

Name	Time	Method
Osteomyelitis evaluation	once a month, until three months, when X-ray shows bone reconstitution .	Radiographs were used when patients presented osteomyelitis