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Completed

NCT Number: NCT03380403

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

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.

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Key information

Conditions

Diabetic Foot Infection Bone Diseases Bone Diseases, Infectious Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Infections Leg Ulcer Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteomyelitis Photo Antimicrobial Chemotherapy Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PDT

Radiation

clinical treatment of infected diabetic foot

Other names: photoantimicrobial chemotherapy

Ciprofloxacin

Other

antibiotics and or surgical debridment

Other names: Conventional treatment

Primary outcomes

  1. Infection control

    Time frame: every month until three months , when blood count- leucocytes reach the standard value.

    blood count - leucocytes for infection

Secondary outcomes

  1. Osteomyelitis evaluation

    Time frame: once a month, until three months, when X-ray shows bone reconstitution .

    Radiographs were used when patients presented osteomyelitis

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina do ABC

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 21, 2017
Registry last updated
Dec 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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