Blu Light for Ulcers Reduction

NCT04018924 | Completed Results

• 1 other identifier: EmoLED_002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

Brief Summary

Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks. The aim of BLUR clinical trial is to verify if the proposed treatment represents a valid and significant remedy for Chronic Venous Insufficiency ulcers. The effectiveness will be measured through the evaluation of the reduction percentage of the lesion area during 10 weeks of treatment comparing the lesion (or portion of it) treated with EmoLED versus the control lesion (or portion of it) treated only according to current Standards of Care(SOC). In the 10 weeks following the recruitment, the patient continues to follow the usual topical therapy with a frequency of once a week visit. The patient will be monitored up to the first event occurring: Complete healing or ten weeks. During the study, reports and evaluations will be made by medical staff on the device safety and usability. 90 patients will be recruited corresponding to the following criteria:

• Subjects suffering from venous, arterial and mixed skin ulcers and surgical dehiscence lesions;
• Presence of similar multiple lesions or lesions larger than 5 cm ;
• Men and women ≥ 18 years old;
• The patient must be able to understand the aims of the clinical study and provide informed consent in writing;
• Chronicity of the lesion: at least 8 weeks. The present clinical trial will be a multi-center prospective, controlled study with the aim of verifying the clinical efficacy of a portable battery-powered device based on blue LEDs. We expect to record at least 20% of the difference between treated lesion and untreated lesion on the same patient during observation time. The treatment, additional to the standard therapy for the patient, will be performed at each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion or on part of it. In case of multiple lesions, one will be treated with EmoLED and one will be selected as a control lesion. In case of a very extensive lesion, it will be divided into two and one half will be the control of the other. All lesions will be cleansed with saline solution and a surgical debridement will be performed with a scalpel if a slough/black base is present. Only then the treatment with EmoLED will begin. If the patient has more than one lesion at the recruitment time, and all lesions are less than 5 cm in diameter, the worst lesions will be treated entirely with the EmoLED device and the others will constitute the control lesions. The evolution of all lesions in the ten weeks of the study duration will be evaluated. If the patient has only one lesion greater than 5 cm in diameter at the recruitment time, the lesion will be divided into two parts along the major side and one half of the lesion area will be treated. The other half of the lesion will be masked with multi-layered sterile gauze during treatment. The point of division of the lesion into two parts will be indicated with an indelible marker and retouched at each visit. If, at the time of recruitment, the patient has more than one lesion with a diameter greater than 5 cm, all lesions will be divided into two along the major side and will be treated as in the previous case. After treatment with EmoLED, a hydrofiber dressing will be applied to the lesion. If clinical signs of infection occur, a hydrofiber dressing with silver will be applied. If necessary, compressive bandage of the limb will be carried out.

Conditions

Leg Ulcers Venous; Dehiscence, Surgical Wound

Keywords

Blue Light; Photo-bio-modulation; ulcers; leg ulcers Venous; dehiscence surgical wound; non healing wound

Outcome Measures

Primary Outcomes (1)

• Size of Wound Remaining Compared to Initial Wound Size

  The primary outcome of the study is the outcomes comparison as remaining wound area surface percentage difference of the lesion treated with EmoLED versus the lesion treated with SOC, both as difference on same patient and within the group of all recruited patients. The primary outcome is measured as the average of the ratio between final areas and initial areas; the ratio of 10 week wound surface area to initial wound surface area was multiplied by 100 to determine the percentage.

  10 weeks

Secondary Outcomes (5)

• Number of Participants With Treatment-Emergent Adverse Events

  10 weeks treatment or in case of adverse event until the patient status return to normal

• Weekly Comparison of Healing Percentage

  10 weeks

• Percentage of Recovered Wounds at 10 Weeks

  10 weeks

• Pain Change

  Week 1 and Week 10

• Event of Recidivism

  20 weeks

Study Arms (1)

T - Treated

EXPERIMENTAL

After standard cleansing or debridement of all wounds, on wound or portion of wound selected for treatment is treated with EmoLED device. Then covered with hydro fibre medication and dressing or compressive dressing when needed on the whole wound (SOC). Treatment is repeated once a week.

Device: Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)

Interventions

Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device) DEVICE

Debridement and Dressing or compressive dressing if needed

Also known as: Standard of Care (SOC)

T - Treated

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects suffering from venous, arterial and mixed skin ulcers and surgical dehiscence lesions;
• Presence of similar multiple lesions or lesions larger than 5 cm ;
• The patient must be able to understand the aims of the clinical study and provide informed consent in writing;
• Chronicity of the lesion: at least 8 weeks.

You may not qualify if:

• Patients who participated in a clinical study on skin ulcers healing during the previous month;
• Patients who are unable to understand the aims and the objectives of the study;
• Patients with neoplastic ulcers;
• Patients with decubitus ulcers;
• Patients with diabet foot ulcers;
• Patients with infected ulcers;
• Patients with ulcers caused by critical ischemia;
• Patients with a past of self-harm that can purposely alter the progress of healing;
• Patients with psychiatric disorders;
• Pregnancy or breast feeding ;
• Patients with neoplasms or other diseases involving the use of cytostatic or immunosuppressive drugs;
• Patients with limited lifespan.

Sponsors & Collaborators

• Emoled: lead
• Akros Bioscience: collaborator
• Phidea Group: collaborator
• Istituto di Fisiologia Clinica CNR: collaborator
• University of Pisa: collaborator

Study Sites (7)

Ospedale Umberto I-Wound and Diabetic foot ambulatory

Bari, 70033, Italy

Location

Barbantini Clinic

Lucca, 55100, Italy

Location

Lucca Hospital

Lucca, Italy

Location

Policlinico G. Martino

Messina, 98124, Italy

Location

ASL Napoli 3 Sud

Naples, 80053, Italy

Location

Saint Luca Clinic

Turin, 10020, Italy

Location

San Lazzaro Hospital - Plastic Surgery Department

Turin, 10100, Italy

Location

Related Publications (17)

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• Nwomeh BC, Yager DR, Cohen IK. Physiology of the chronic wound. Clin Plast Surg. 1998 Jul;25(3):341-56.

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• Adamskaya N, Dungel P, Mittermayr R, Hartinger J, Feichtinger G, Wassermann K, Redl H, van Griensven M. Light therapy by blue LED improves wound healing in an excision model in rats. Injury. 2011 Sep;42(9):917-21. doi: 10.1016/j.injury.2010.03.023.

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• Son GY, Hong JH, Chang I, Shin DM. Induction of IL-6 and IL-8 by activation of thermosensitive TRP channels in human PDL cells. Arch Oral Biol. 2015 Apr;60(4):526-32. doi: 10.1016/j.archoralbio.2014.12.014. Epub 2014 Dec 25.

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• Bertin S, Aoki-Nonaka Y, de Jong PR, Nohara LL, Xu H, Stanwood SR, Srikanth S, Lee J, To K, Abramson L, Yu T, Han T, Touma R, Li X, Gonzalez-Navajas JM, Herdman S, Corr M, Fu G, Dong H, Gwack Y, Franco A, Jefferies WA, Raz E. The ion channel TRPV1 regulates the activation and proinflammatory properties of CD4(+) T cells. Nat Immunol. 2014 Nov;15(11):1055-1063. doi: 10.1038/ni.3009. Epub 2014 Oct 5.

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• Xu T, Wu BM, Yao HW, Meng XM, Huang C, Ni MM, Li J. Novel insights into TRPM7 function in fibrotic diseases: a potential therapeutic target. J Cell Physiol. 2015 Jun;230(6):1163-9. doi: 10.1002/jcp.24801.

  PMID: 25204892 BACKGROUND

• Kleinpenning MM, Smits T, Frunt MH, van Erp PE, van de Kerkhof PC, Gerritsen RM. Clinical and histological effects of blue light on normal skin. Photodermatol Photoimmunol Photomed. 2010 Feb;26(1):16-21. doi: 10.1111/j.1600-0781.2009.00474.x.

  PMID: 20070834 BACKGROUND

• Cicchi R, Rossi F, Alfieri D, Bacci S, Tatini F, De Siena G, Paroli G, Pini R, Pavone FS. Observation of an improved healing process in superficial skin wounds after irradiation with a blue-LED haemostatic device. J Biophotonics. 2016 Jun;9(6):645-55. doi: 10.1002/jbio.201500191. Epub 2016 Jan 12.

  PMID: 26756549 BACKGROUND

• Rossi et al. (2010), A blue-LED-based device for selective photocoagulation of superficial abrasions: theoretical modeling and in vivo validation, Photonic Therapeutics and Diagnostics VI, Proceedings of SPIE Volume: 7548.

  BACKGROUND

• Meaume S, Dissemond J, Addala A, Vanscheidt W, Stucker M, Goerge T, Perceau G, Chahim M, Wicks G, Perez J, Tacca O, Bohbot S. Evaluation of two fibrous wound dressings for the management of leg ulcers: results of a European randomised controlled trial (EARTH RCT). J Wound Care. 2014 Mar;23(3):105-6,108-11, 114-6. doi: 10.12968/jowc.2014.23.3.105.

  PMID: 24633056 BACKGROUND

• Hansson C. The effects of cadexomer iodine paste in the treatment of venous leg ulcers compared with hydrocolloid dressing and paraffin gauze dressing. Cadexomer Iodine Study Group. Int J Dermatol. 1998 May;37(5):390-6. doi: 10.1046/j.1365-4362.1998.00415.x.

  PMID: 9620490 BACKGROUND

• Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA. Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency. J Vasc Surg. 1999 Sep;30(3):491-8. doi: 10.1016/s0741-5214(99)70076-5.

  PMID: 10477642 BACKGROUND

• F. Petrella, Progetto SIUC (Studio Incidenza Ulcere Cutanee), 1 gennaio 2015 - 31 dicembre 2016, AIUC

  BACKGROUND

• M. Fraccalvieri "Le terapie della deiscenza dell'incisione chirurgica" Ediz Minerva Medica, pag 17, Aprile 2015, Torino, Italy, ISBN 9-788877-118325

  BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer; Surgical Wound Dehiscence; Ulcer

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Results Point of Contact

• Title: Duccio Rossi Degl'Innocenti
• Organization: Emoled

d.rossi@emoled.com

+39 0550751981

Study Officials

• Marco Fraccalvieri, Doctor

  A.O.U. Città della Salute e della Scienza

  PRINCIPAL INVESTIGATOR

• Stefano Gasperini, Doctor

  Medical Advisor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patient used as control of himself: If a patient carries a wound with a diameter larger than 5 cm the wound is divided in two parts on treated with the Device the other covered and used as control, if the patient has two or more separate wounds each smaller than 5 cm in diameter the worst of them is treated the others used as control.

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: April 4, 2018
• Primary Completion: November 17, 2019
• Study Completion: December 22, 2019
• Last Updated: May 19, 2021
• Results First Posted: May 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)