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Effect of laser on Diabetic Foot: randomized clinical trial

Effectiveness of Laser therapy in Diabetic Foot: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9vv5rsw
Enrollment
Unknown
Registered
2022-10-04
Start date
2022-04-06
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Diabetic Foot

Interventions

Participants will be followed up for 12 weeks, attending the outpatient consultation once a week, where biological material will be collected at the first consultation (T0), at the fifth consultation
E07.632.490

Sponsors

Faculdade de Enfermagem - Universidade Estadual de Campinas
Lead Sponsor
Universidade Federal Fluminense
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants with diabetes mellitus; both genders; aged 18 or over; foot wound

Exclusion criteria

Exclusion criteria: Lupus; pyoderma gangrenosum; Steve Johnson Syndrome.

Design outcomes

Primary

MeasureTime frame
Change in wound area size from initiation of treatment to end of follow-up period, 12 weeks. The difference in the area of the wound will be evaluated through the weekly photographs, the photos will be inserted in the ImageJ software that calculates the area in square centimeters.

Secondary

MeasureTime frame
Wound area reduction will be measured in square centimeters (cm2), length x width of the area will be measured in cm2 and area change calculated in percentage (%). Wound closure will be expressed in %, calculated by the following mathematical formula, called the ulcer contraction index (ICU): ICU= Initial wound area- (Daily area)(Initial area) x 100% ;Analysis of the expression of inflammatory cytokines using the polymerase chain reaction (PCR) technique and enzyme-linked immunosorbent assay (ELISA);The appearance of tissue quality in the wound bed (granulation tissue), decrease in exudate, appearance and contraction of edges will be assessed using the Bates-Jansen Wound Assessment Tool.

Countries

Brazil

Contacts

Public ContactBeatriz Barbieri

Faculdade de Enfermagem - Universidade Estadual de Campinas

beatriz_barbieri13@hotmail.com+55 (011) 997720815

Outcome results

None listed

Source: REBEC (via WHO ICTRP)