An interventional study of PDT and Ciprofloxacin in Diabetic Foot Infection, Osteomyelitis and Photo Antimicrobial Chemotherapy, sponsored by Faculdade de Medicina do ABC. Completed. Open to participants aged 18 Years to 83 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-28.
Sponsored by Faculdade de Medicina do ABC · Not applicable, Interventional, and Treatment
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.
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.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's enrollment of 34 is below the median of 74 across 60 interventional studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Faculdade de Medicina do ABC is the lead sponsor of 26 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Methylene blue and Photon Irradiation , every each week, until total ulcer healing.
Radiation: PDT
Diabetic foot patients were treated on conventional way, using antibiotics and surgery.
Other: Ciprofloxacin
clinical treatment of infected diabetic foot
Also known as: photoantimicrobial chemotherapy
antibiotics and or surgical debridment
Also known as: Conventional treatment
Infection control
blood count - leucocytes for infection
Time frame: every month until three months , when blood count- leucocytes reach the standard value.
Osteomyelitis evaluation
Radiographs were used when patients presented osteomyelitis
Time frame: once a month, until three months, when X-ray shows bone reconstitution .
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Faculdade de Medicina do ABC