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Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers.

2026년 9월 1일 업데이트: Rebeca Boltes Cecatto, University of Nove de Julho

Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers: A Randomized Clinical Study Monitored by Dark-Field Microscopy and Infrared Thermography

Foot ulcers in people with diabetes mellitus represent one of the most serious chronic complications of the disease, being associated with persistent inflammation, high oxidative stress, microvascular dysfunction and systemic hemorheological changes that compromise the progression of the healing process. Given the pathophysiological complexity of these injuries, therapeutic strategies capable of acting simultaneously on the local wound microenvironment and the systemic biological environment become relevant for optimizing tissue repair. This study aims to evaluate the effects of the association between transcutaneous vascular photobiomodulation (FBMVT) and topical photobiomodulation (FBMT) in people with diabetes and foot ulcers. This is a randomized, controlled and prospective phase II clinical trial, with a sample of 20 participants allocated to experimental groups that will receive a standard dressing with neutral healing matrix (TLC) or a protocol combining FBMVT and FBMT. FBMVT will be performed with a 660 nm laser, 100 mW power, continuous mode and 180 J per application, monthly for 12 weeks, totaling four sessions. FBMT will be performed with a 660 nm laser, 100 mW power, 2 J energy per point, twice a week during dressing changes, totaling approximately 24 sessions throughout follow-up. The primary outcome will be the reduction in the area of the lesion (cm²), measured using a standardized planimetric method. As secondary outcomes, the Pressure Ulcer Scale for Healing (PUSH) score will be evaluated, the standardized infrared thermographic assessment of the monthly perilesional region of all participants and the qualitative analysis of peripheral blood by dark field microscopy (MCE) pre and post FBMVT of the intervention group. The data will be analyzed using repeated measures ANOVA, after evaluating the normality of the data, adopting a significance level of 5%. It is expected to observe a reduction in the lesion area, improvement in clinical healing scores, favorable changes in the hemocirculatory dynamics observed in ECM and modulation of thermal patterns related to tissue perfusion, indicating that systemic and local biophotonic modulation can contribute to the optimization of the healing process in foot ulcers in people with diabetes.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

20

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 브라질
    • Piauí
      • Teresina, Piauí, 브라질
        • 모병
        • Universidade Estadual do Piaui
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Medical diagnosis of Diabetes Mellitus type 1 or 2;
  • Presence of a foot ulcer with duration ≥ 4 weeks, characterizing a chronic ulcer;
  • Age ≥ 18 years;
  • Ankle-brachial index compatible with adequate perfusion, allowing for the safe conduct of treatment;
  • Wagner Grade I or Wagner Grade II classification of DM ulcer
  • Ability to understand the objectives of the study and signature of the ICF (Informed Consent Form). -

Exclusion Criteria:

  • Having more than one ulcer to be treated, regardless of etiology;
  • Presence of hematological diseases that may interfere with peripheral blood analysis, such as: hemolytic anemias, hemoglobinopathies (sickle cell anemia), leukemias, lymphomas, multiple myeloma, or other blood dyscrasias that may significantly interfere with cell morphology or peripheral blood analysis;
  • Active systemic infection at the time of enrollment;
  • Active neoplasia undergoing treatment or under investigation;
  • Use of immunosuppressants or corticosteroids;
  • Pregnant or breastfeeding women;
  • Use of photosensitizing medications;
  • Allergy or sensitivity to any of the study interventions;
  • Clinical signs of infection, necrosis, devitalized tissue, or wound colonization.
  • Acute clinical conditions that contraindicate participation, whether related or unrelated to DM.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: PBM Treatment Group
PBM group
방사능: PBM - Photobiomodulation
Application of transcutaneous PBM therapy to the foot ulcer Photobiomodulation (PBM)-formerly referred to as low-level laser therapy (LLLT) or cold laser therapy-is a non-invasive, non-thermal therapeutic modality that employs light in the red to near-infrared spectrum (typically spanning wavelengths from approximately 600 nm to 1,100 nm) to elicit beneficial biological responses in target tissues.
다른 이름들:
  • 저수준 레이저 치료
다른: Standard Treatment
cutaneous standard dressing with neutral healing matrix (TLC)
다른 이름들:
  • Standard dressing with neutral healing matrix (TLC)
위약 비교기: PBM Placebo Group
PBM placebo group
다른: Standard Treatment
cutaneous standard dressing with neutral healing matrix (TLC)
다른 이름들:
  • Standard dressing with neutral healing matrix (TLC)
방사능: Placebo PBM
Application of transcutaneous PBM therapy - device switched off-

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Size of wound area
기간: At the basal assessment (baseline), immediately before the PBM therapy, and 12 weeks of treatment

Wound area (cm²). To obtain the wound area, a standardized two-dimensional measurement technique will be used, considering the greatest length (longitudinal axis) and the greatest width perpendicular to the length (transverse axis), with area estimated using the formula:

Area (cm²) = length × width

This method is widely accepted in clinical practice and clinical studies, especially when combined with evaluator standardization and systematic photographic documentation, and is recommended by international guidelines for longitudinal wound monitoring (IWGDF, 2023; EWMA, 2022).
At the basal assessment (baseline), immediately before the PBM therapy, and 12 weeks of treatment

2차 결과 측정

결과 측정
측정값 설명
기간
Rate of area reduction over time
기간: At the basal assessment (baseline), immediately before the weekly PBM therapy. and 12 weeks of treatment
percentage (%) reduction from baseline area, as recommended by international consensus guidelines for outcome assessment in chronic wounds (IWGDF, 2023; EWMA, 2022).
At the basal assessment (baseline), immediately before the weekly PBM therapy. and 12 weeks of treatment
Healing Wound Progression
기간: At the basal assessment (baseline), and 12 weeks of treatment
The assessment of healing progression will be performed using the Pressure Ulcer Scale for Healing (PUSH), developed by Bryant & Nix in 1997 and validated by the National Pressure Ulcer Advisory Panel (NPUAP) (NPUAP, 1998; Bryant & Nix, 1997).
At the basal assessment (baseline), and 12 weeks of treatment
Pain Intensity
기간: At the basal assessment (baseline), immediately before the weekly PBM therapy, and 12 weeks of treatment
The presence of pain in the cutaneous reference region of the triceps surae will be assessed using a Numerical Pain Scale (NPS) / The NPS is an aid in measuring the intensity of pain felt by the patient, an important instrument to verify progress and analyze the treatment instituted. The participant should be asked about their level of pain, where 0 means total absence of pain and 10 the maximum pain level.
At the basal assessment (baseline), immediately before the weekly PBM therapy, and 12 weeks of treatment
Thermographic wound temperature
기간: At the basal assessment (baseline), and 12 weeks of treatment
Thermographic assessment will be performed using a portable infrared camera (FLIR C5) (Figure 3), with a spectral range of 7.5-14 µm (thermal infrared), thermal resolution of 160 × 120 pixels, sensitivity ≤ 0.05 °C (50 mK), and accuracy of ±2 °C or ±2%. Emissivity was set at 0.98 for adequate representation of the skin surface.
At the basal assessment (baseline), and 12 weeks of treatment
Blood cell morphology
기간: At the basal assessment (baseline), and 12 weeks of treatment
Blood cell morphology will be assessed using dark-field microscopy methodology.
At the basal assessment (baseline), and 12 weeks of treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Nove de Julho

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 12일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2027년 3월 1일

연구 등록 날짜

최초 제출

2026년 8월 28일

QC 기준을 충족하는 최초 제출

2026년 8월 28일

처음 게시됨 (실제)

2026년 9월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 1일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DMPBMThermo

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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