Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot

NCT06416462 | Completed

• 1 other identifier: 6.296.354
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic foot ulcer affects 10.5% of the Brazilian/world population, compromising the quality of life of these patients and burdening the public health system. Studies show that antimicrobial photodynamic therapy (aPDT) accelerates its repair, however, there is not enough evidence for decision-making in clinical practice, which prevents this treatment from being used on a large scale. Controlled and randomized clinical studies are needed to increase the level of evidence on this subject, promoting the improvement of the quality of life of people affected by diabetic foot ulcers. The aim of this study is to analyze the action of antimicrobial photodynamic therapy on the quality of the wound and tissue repair process using the Bates-Jensen scale in people affected by diabetic foot wounds.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (5)

• Bates-Jensen Wound Assesment Tool

  The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.

  Before the intervention

• Bates-Jensen Wound Assesment Tool

  The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.

  Day after the first session

• Bates-Jensen scale

  The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.

  Day after the third session

• Bates-Jensen scale

  The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.

  Day after the fifth session

• Bates-Jensen scale

  The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5, where 1 indicates the best wound condition, and 5 represents the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with higher scores indicating worse wound conditions.

  Day after the tenth session

Secondary Outcomes (45)

• Diabetes twenty-one instrument

  Before the intervention

• Diabetes twenty-one instrument

  Day after the first session

• Diabetes twenty-one instrument

  Day after the third session

• Diabetes twenty-one instrument

  Day after the fifth session

• Diabetes twenty-one instrument

  Day after the tenth session

Study Arms (2)

Simulation of antimicroial Photodynamic therapy group

PLACEBO COMPARATOR

Participants in the control group will be treated in exactly the same way as the aPDT group, however the light treatment will be simulated. The device will be placed in position, however it will be switched off. After three weeks of monitoring in the control group, the patient will be informed that they were in the placebo group and will be offered treatment with aPDT and irradiation, for ethical reasons.

Antimicrobial Photodynamic therapy group

ACTIVE COMPARATOR

In the experimental group (aPDT), 1% methylene blue applied with the aid of a syringe will be used as a photosensitizer (with a pre-irradiation time of 5 minutes, 6 J of red laser will be applied.

Procedure: antimicrobial photodynamic therapy

Interventions

antimicrobial photodynamic therapy PROCEDURE

When starting the research, all wounds, regardless of the study group, will be cleaned with 0.9% saline solution (SF0.9%), using a 40x12 needle and a 500ml bottle of SF0.9%, in order to maintain pressure. for equal cleaning of all wounds and a hydrofiber plate with silver was used as standard coverage. Experimental group (n=45): When starting the intervention, all services in both groups will follow the cleaning standard described previously. In the aPDT group, 1% methylene blue will be used as a photosensitizer applied with the aid of a syringe (with a pre-irradiation time of 5 minutes), 6 J of laser will be applied.

Antimicrobial Photodynamic therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both sexes
• chronic wounds originating from the neuropathic diabetic foot
• contaminated lesions
• total score obtained on the Bates-Jensen scale between 13 and 60
• who submits all requested exams

You may not qualify if:

• wounds with etiologies that are not related to the diabetic foot
• ischemic diabetic foot who has an ankle-brachial index with a value between 0.7 and 1.3.
• glycated hemoglobin greater than 8%.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Raquel Agnelli Mesquita-Ferrari

São Paulo, São Paulo, 11030-480, Brazil

Location

Related Publications (1)

• Chagas PF, Dos Santos TB, Dos Santos Trivino G, Bussadori SK, Duran CCG, Fernandes KPS, Cecatto RB, Horliana ACRT, Mesquita-Ferrari RA. Antimicrobial Photodynamic Therapy in Diabetic Amputation Ulcers: Case Series Evaluating Wound Healing Quality. Lasers Surg Med. 2025 Aug;57(6):457-465. doi: 10.1002/lsm.70037. Epub 2025 Jun 22.

  PMID: 40545698 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Raquel Agnelli Mesquita-Ferrari, PhD

  University of Nove de Julho

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical colaborator

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: May 16, 2024
• Study Start: July 30, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

BR (1)