Blue Light Photobiomodulation Therapy on Neuroischemic Patients

NCT04831606 | Terminated

• 1 other identifier: EmoLED_DF_001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Percentage of healed lesions on the total lesions treated for each arm

  Percentage of lesions showing a lasting and complete re-epithelialization in each group after twenty-four weeks. Healing must be confirmed by the Principal Investigator or his staff during an outpatient visit at the reference center participating in the study

  24 weeks (20 weeks treatment plus 4 weeks post treatment observation)

Secondary Outcomes (1)

• Healing time

  24 weeks

Other Outcomes (8)

• Reduction of the lesion surface in both arms, measured in absolute terms (square centimeters) and as % of the initial size.

  once every 4 weeks for 20 weeks plus the last control visit at 24 weeks if needed

• Quality of life level (QoL), measured with specific questionnaires (EuroQoL-5D)

  16 weeks (last outpatient visit)

• Pain perception measured according to the VAS scale

  20 weeks

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

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.

Procedure: debridement; Device: Offloading; Device: Advanced dressing

EmoLED Arm

EXPERIMENTAL

Patients on top of the standard treatment of the control arm will receive EmoLED blue light irradiation for two minutes at each biweekly medication.

Procedure: debridement; Device: Offloading; Device: Advanced dressing; Device: Blue Light Photobiomodulation

Interventions

debridement PROCEDURE

Cleaning of the wound area

Control Arm; EmoLED Arm

Offloading DEVICE

Offloading performed with a standard brace to the calf (Optima Diab, from Molliter).

Control Arm; EmoLED Arm

Advanced dressing DEVICE

Protect the wound with Advanced dressing

Control Arm; EmoLED Arm

Blue Light Photobiomodulation DEVICE

2 minutes irradiation of blue light performed with EmoLED device

EmoLED Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Patients who have participated in a clinical study with a drug or medical device for less than a month;
• 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 who underwent revascularization in the previous two months;
• Patients who have presented an acute ischemic event within the previous 3 months;
• Patients with heel injuries;
• Patients with nephropathy undergoing dialysis;
• Patients with osteomyelitis;
• Patients with Charcot's neuro-arthropathy:
• Patient on high dose corticosteroid therapy (≥ 40 mg/day);
• Patients with a history of self-harm who can voluntarily alter the course of healing;
• Patients with psychiatric disorders;
• Women who are pregnant or breastfeeding;

Sponsors & Collaborators

• Emoled: lead
• Ospedale San Donato: collaborator
• University of Pisa: collaborator

Study Sites (1)

San Donato Hospital

Arezzo, 52100, Italy

Location

Related Publications (2)

• Greenhalgh DG. Management of Burns. N Engl J Med. 2019 Jun 13;380(24):2349-2359. doi: 10.1056/NEJMra1807442. No abstract available.

  PMID: 31189038 BACKGROUND

• Mast BA, Schultz GS. Interactions of cytokines, growth factors, and proteases in acute and chronic wounds. Wound Repair Regen. 1996 Oct;4(4):411-20. doi: 10.1046/j.1524-475X.1996.40404.x.

  PMID: 17309691 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

Debridement

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Alberto Piaggesi, Doctor

  Pisa University Hospital

  STUDY CHAIR

• Alessia Scatena, Doctor

  San Donato Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized into the two arms of the study according to a list of random numbers generated by special IT tools and communicated by the scientific supervisor to the Care Provider via e-mail . It is a 1: 1, single-block randomization of 40 patients distributed in the two groups (treated and control). After the two-week enrollment observation period, the Investigator at the outpatient center will ascertains the conditions for the study prosecution and will notify the Head of the Care Providers to take charge of the patient included in the study and to proceed with the assignment to one of the groups. In this way, the Investigator at the outpatient center will be blinded to the treatment performed at home by the patient. All patients will receive a pair of blinding glasses at the enrollment and will be required to wear them during therapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A double-blind pilot trial on outpatients affected by diabetic foot ulcers, followed in an integrated way by both a specialized center and the home nursing network, for a period of 24 weeks. The specialist center will characterize the patient, set the therapy, and evaluate them monthly, the nursing service will treat them at home biweekly. The physician in charge of the monthly evaluation is unaware of the patient's arm. During therapy, the patient will wear blinding glasses, the control arm will simulate the use of the device switching it on without aiming it at the wound. After a two-week pre-enrollment period to evaluate the wound progression applying only the standard care (if the wound reduces 50% or more, the patient will be excluded), the patient will be randomized into one of the study arms: the control arm will continue with the standard treatment, while the EmoLED Arm will receive EmoLED's therapy in addition to the standard treatment.

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start: July 31, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)