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

ABC Foundation (FUABC)

Status: Completed

Conditions: Diabetic Foot Infection; Osteomyelitis; Photo Antimicrobial Chemotherapy

Treatments: Other: Ciprofloxacin; Radiation: PDT

Study type: Interventional

Funder types: Other

Identifiers

NCT03380403

Faculdade de medicina do ABC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 83 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

PDT

Active Comparator group

Description:

Methylene blue and Photon Irradiation , every each week, until total ulcer healing.

Treatment:

Radiation: PDT

Ciprofloxacin

Active Comparator group

Description:

Diabetic foot patients were treated on conventional way, using antibiotics and surgery.

Treatment:

Other: Ciprofloxacin