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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03380403

Enrollment

Registered

2017-12-21

Start date

2010-01-01

Completion date

2012-01-01

Last updated

2017-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Infection, Osteomyelitis, Photo Antimicrobial Chemotherapy

Keywords

diabetic foot, Osteomyelitis, PACT, PDT, Singlet oxygen, antimicrobial, diabetes, Wagner scale

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.

Interventions

RADIATIONPDT

clinical treatment of infected diabetic foot

OTHERCiprofloxacin

antibiotics and or surgical debridment

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

non-randomized clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 83 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026