A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Faculdade de Medicina do ABC
- Enrollment
- 34
- Primary Endpoint
- Infection control
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 83 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age > 18 years old
- •diabetic foot
- •Wagner grade III
Exclusion Criteria
- •age < 18 years old
- •non-diabetic
- •Wagner IV and V
Arms & Interventions
Ciprofloxacin
Diabetic foot patients were treated on conventional way, using antibiotics and surgery.
Intervention: Ciprofloxacin (Other)
PDT
Methylene blue and Photon Irradiation , every each week, until total ulcer healing.
Intervention: PDT (Radiation)
Outcomes
Primary Outcomes
Infection control
Time Frame: every month until three months , when blood count- leucocytes reach the standard value.
blood count - leucocytes for infection
Secondary Outcomes
- Osteomyelitis evaluation(once a month, until three months, when X-ray shows bone reconstitution .)
Investigators
João Paulo Tardivo
Principal Investigator
Faculdade de Medicina do ABC