Blue Light Photobiomodulation Therapy on Neuroischemic Patients
A legfontosabb adatok
- Ki végzi
- Emoled
- Hol
- Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Leállítva
- Résztvevők
- 21 fő vett részt
- Kezdés
- 2021. júl. 31.
- Befejezés
- 2024. júl. 1.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- debridement
- Offloading
- Advanced dressing
- Blue Light Photobiomodulation
- A regiszteradat frissítve
- 2024. november 27.
- Miért állt le
- very low enrollment rate
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 26 feltétel megnézéseKevesebb
Ki vehet részt
- Patients suffering from neuro-ischemic diabetic foot ulcer grade IC or IIC according to the University of Texas Wound Classification; If the patient has two or more lesions, which may fall within the inclusion criteria, the most serious lesion (index lesion) will be selected and followed for the entire duration of the study
- Patients who, following hospital discharge or after the first outpatient assessments, are followed by Home Care and are always monitored at the same referral center
- Patients with type I or II diabetes, with blood glucose ≤ 10%
- Patients willing to constantly wear the offload braces prescribed by the reference center
- Patients with ulcer localized on the finger, lateral, plantar, or dorsal part of the foot with an extension greater than 1 sqcm
- Patients with confirmed neuropathy with Monofilament (Semmes-Weinstein 5.07 / 10g)
- Patients with ABPI between 0.7 - 0.9, ankle PA> 70mmHg, TcPO2 between 36 - 50 mmHg
- Patients with lesions lasting between 1 and 24 months
- Patients who understand the purpose of the Clinical Study and provide their informed consent in writing
Ki nem vehet részt
- Patients who have participated in a clinical study with a drug or medical device for less than a month
- Patients who underwent revascularization in the previous two months
- Patients who have presented an acute ischemic event within the previous 3 months
- Patient on high dose corticosteroid therapy (≥ 40 mg/day)
- Patients with pathologies or under treatment with drugs that induce photosensitization of the skin
- Patients with a history of self-harm who can voluntarily alter the course of healing
- Patients with psychiatric disorders
- Patients who are unable to understand the aims and objectives of the study
- Patients who are bedridden or unable to walk or Patients with neoplasms
- Patients with pressure ulcers
- Patients who have infectious signs according to IDSA criteria
- Patients with heel injuries
- Patients with nephropathy undergoing dialysis
- Patients with osteomyelitis
- Patients with Charcot's neuro-arthropathy:
- Women who are pregnant or breastfeeding
- Patients with a life expectancy of less than one year
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
This is a pilot case/control clinical study on a group of outpatients with diabetic foot lesions aiming to verify the efficacy and safety of the Blue light photobiomodulation therapy with EmoLED medical device, in addition to standard therapy compared to the standard therapy alone, evaluating the percentage of healed lesions (which have reached complete and lasting re-epithelialization), the evaluation of the healing time and reduction of the ulcerated area during the time of observation, the perception of pain and the quality of life of the enrolled patients.
A teljes eredeti leírásKevesebb
The aim of this study is therefore to determine any differences in outcome between the two groups considered and, in particular, if the therapy of the group being treated is more effective than the standard therapy in terms of percentage of healed lesions, healing time, and reduction of the ulcerated area, pain perception, and quality of life, and is at least as safe in terms of occurrence of adverse events.
A vizsgálat 2 csoportja
- Control ArmMár használt kezelés, összehasonlításként
Patients will receive a biweekly standard treatment at home according to the International Working Group on Diabetic Foot consisting of: Debridement of the lesion, unloading with a brace up to the calf, non-removable (except for contraindications), dressing of the wound with advanced dressings in use at the specialized center and in the home care network.
Kezelés: debridement, Offloading és Advanced dressing
- EmoLED ArmA vizsgált kezelés
Patients on top of the standard treatment of the control arm will receive EmoLED blue light irradiation for two minutes at each biweekly medication.
Kezelés: debridement, Offloading, Advanced dressing és Blue Light Photobiomodulation
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Single-center Prospective Randomized Controlled Study on the Efficacy of Blue Light in the Therapy of Neuro-ischemic Foot Lesions in Patients With Type I or II Diabetes in a Combined Hospital /Territory Treatment Regimen.
- A regiszteradat frissítve
- 2024. november 27.