NCT03380403

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Faculdade de Medicina do ABC · Academic / Other
• Sex: All
• Age: 18 Years – 83 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetic Foot Infection
• Osteomyelitis
• Photo Antimicrobial Chemotherapy

Interventions

Type	Name	Description
RADIATION	PDT	clinical treatment of infected diabetic foot
OTHER	Ciprofloxacin	antibiotics and or surgical debridment

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2017-12-21
• Last updated: 2017-12-28