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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot Infection, Osteomyelitis, Photo Antimicrobial Chemotherapy

Intervention / Treatment
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* Radiation: PDT
* Other: Ciprofloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 83 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: non-randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PDT<br>Methylene blue and Photon Irradiation , every each week, until total ulcer healing. | Radiation: PDT<br>* clinical treatment of infected diabetic foot<br>* Other names: photoantimicrobial chemotherapy;|
| Active Comparator: Ciprofloxacin<br>Diabetic foot patients were treated on conventional way, using antibiotics and surgery. | Other: Ciprofloxacin<br>* antibiotics and or surgical debridment<br>* Other names: Conventional treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection control | blood count - leucocytes for infection | every month until three months , when blood count- leucocytes reach the standard value. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteomyelitis evaluation | Radiographs were used when patients presented osteomyelitis | once a month, until three months, when X-ray shows bone reconstitution . | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot, PDT, Osteomyelitis, PACT, Singlet oxygen, antimicrobial, diabetes, Wagner scale