Clinical trial NCT03380403: A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients
Official title: A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Infection
Osteomyelitis
Photo Antimicrobial Chemotherapy
Keywords: diabetic foot
Osteomyelitis
PACT
PDT
Singlet oxygen
antimicrobial
diabetes
Wagner scale
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2017-12-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: non-randomized clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infection control
timeFrame: every month until three months , when blood count- leucocytes reach the standard value.
Secondary outcomes:
measure: Osteomyelitis evaluation
timeFrame: once a month, until three months, when X-ray shows bone reconstitution .
Other outcomes:
Locations:
Study officials:
References:
citation: Wainwright M, Maisch T, Nonell S, Plaetzer K, Almeida A, Tegos GP, Hamblin MR. Photoantimicrobials-are we afraid of the light? Lancet Infect Dis. 2017 Feb;17(2):e49-e55. doi: 10.1016/S1473-3099(16)30268-7. Epub 2016 Nov 22.
citation: Tardivo JP, Baptista MS, Correa JA, Adami F, Pinhal MA. Development of the Tardivo Algorithm to Predict Amputation Risk of Diabetic Foot. PLoS One. 2015 Aug 17;10(8):e0135707. doi: 10.1371/journal.pone.0135707. eCollection 2015.
citation: Abrahamse H, Hamblin MR. New photosensitizers for photodynamic therapy. Biochem J. 2016 Feb 15;473(4):347-64. doi: 10.1042/BJ20150942.
citation: Sahu K, Sharma M, Dube A, Gupta PK. Topical antimicrobial photodynamic therapy improves angiogenesis in wounds of diabetic mice. Lasers Med Sci. 2015 Sep;30(7):1923-9. doi: 10.1007/s10103-015-1784-8. Epub 2015 Jul 10.