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

Osteomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380403
• Other study ID #: Faculdade de medicina do ABC
• Status: Completed
• Phase: N/A
• First received: November 24, 2017
• Last updated: December 26, 2017
• Start date: January 1, 2010
• Est. completion date: January 1, 2012

Study information

• Verified date: December 2017
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 1, 2012
• Est. primary completion date: January 1, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 83 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Infection
• Osteomyelitis
• Photo Antimicrobial Chemotherapy

Intervention

Radiation:
• PDT
clinical treatment of infected diabetic foot

Other:
• Ciprofloxacin
antibiotics and or surgical debridment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC	Fundação de Amparo à Pesquisa do Estado de São Paulo

References & Publications (4)

Abrahamse H, Hamblin MR. New photosensitizers for photodynamic therapy. Biochem J. 2016 Feb 15;473(4):347-64. doi: 10.1042/BJ20150942. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection control	blood count - leucocytes for infection	every month until three months , when blood count- leucocytes reach the standard value.
Secondary	Osteomyelitis evaluation	Radiographs were used when patients presented osteomyelitis	once a month, until three months, when X-ray shows bone reconstitution .