Leg Ulcers Standards of Care Enhancement

NCT04689009 | Completed Results

• 1 other identifier: EmoLED_003
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 5

Brief Summary

Multi-center, prospective,randomized controlled study on the speed of healing, life quality and cost-effectiveness of the treatment with a blue light medical device (EmoLED) versus existing Standards Of Care (SOC) for patients with leg ulcers. The aim of LUCE - "Leg Ulcers Standards of Care Enhancement" clinical trial is to verify the clinical efficacy of a portable battery-powered device blue LEDs based. This study aims to compare the existing SOC (consisting in two visits per week) to a protocol that requires only one visit per week, during which the EmoLED treatment is administered in addition to the current therapy. It is expected to register a difference in efficacy between EmoLED Group and SOC Group, in terms of "healing rate", intended as a reduction of the wound area, but also as a progress, in a broad sense, of the overall clinical situation of the lesion, in terms of pain and quality of life.

• Endpoint- The primary endpoint is the comparison of the outcomes in terms of healing rate of lesions treated with SOC (SOC Group) versus lesions treated with EmoLED (EmoLED Group), on week 16th. Patients 80 patients will be recruited (40 patients per group), following these inclusion/exclusion criteria: Inclusion criteria:
• Subjects suffering from venous and mixed skin ulcers;
• Presence of a lesion \< 100 cm² of area and \< 1 cm in depth;
• Men and women ≥ 18 years old;
• The patient must be able to understand the aims of the clinical trial and provide informed consent in writing;
• Chronicity of the lesion: at least 8 weeks. Exclusion criteria:
• Patients who participated in clinical trials about skin ulcers healing during the previous month;
• Patients who are not able to understand the aims of the trial;
• Patients with pressure ulcers;
• Patients with diabetic foot ulcers;
• Patients with circumferential leg ulcer (due to the difficulties in analysing the pictures);
• Patients with clearly infected ulcers or with systemic infection;
• Patients with ulcers caused by critical ischemia;
• Patients with a self-harm past that can purposely alter the process 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;
• Patients with photosensitizing illnesses or that take photosensitizing drugs. All inclusion and exclusion criteria must be satisfied before recruitment. Any concomitant phar-macological therapy must be maintained.
• Medical and surgical procedures- The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied. Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic la-tex-free bandage will be carried out. The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion. In case of multiple lesions matching with both inclusion and exclusion criteria, they will be all treated following the same protocol, depending on the group to which the patient belongs; in this case the Principal Investigator will fill out a data-collection form and take pictures just of the le-sion with the wider area.
• Follow up procedure- The patient is called upon to go to the follow-up check after 4 weeks from the healing or, other-wise, from the end of the trial (16 weeks). The follow-up visit will be used to confirm the occurred healing and verify the absence of relapses and/or undesirable effects (if the wound appeared completely healed) or to value the healing progress for the unhealed lesions.

Conditions

Venous Leg Ulcer; Mixed Leg Ulcer

Keywords

leg ulcer; photobiomodulation; blue light; wound healing

Outcome Measures

Primary Outcomes (1)

• Percentage Change of the Wound Area

  It is expected to demonstrate the equivalence between EmoLED Group treatment (consisting in EmoLED treatment + SOC treatment, once a week) and SOC Group treatment (consisting in SOC treatment, twice a week), in terms of percentage change of the wound area, at week 16 and at Follow-up visit (at week 20) from baseline. The percentage reduction is measured by calculating: (initial area of the wound - final area of the wound) / initial area of the wound x 100.

  Baseline,16 weeks, 20 weeks

Secondary Outcomes (6)

• Healing Time Evaluation

  16 weeks

• Incidence of the Treatment (Standard vs EmoLED Protocol) in Life Quality

  16 weeks

• Costs Related Evaluation

  16 weeks

• Percent Change in VAS Scale Evaluation

  16 weeks

• Satisfaction, Complexity and Helpfulness Evaluation of the Device Assessed by SUS

  16 weeks

Study Arms (2)

SOC Group

ACTIVE COMPARATOR

SOC Group (or control group) will follow the standard therapy with visits twice a week. More specifically, the treatment consists of: dressing change, cleansing and eventual debridement of the lesion, the topic treatment and compression bandage.

Procedure: current Standards Of Care

EmoLED Group

EXPERIMENTAL

EmoLED Group will be visited once a week. Therapy in this case includes, in addition to the standard therapy, a treatment with EmoLED device; it consists in irradiating each 5 cm diameter area of the lesion for 60 seconds, with the blue light emitted by the device. For lesions larger than 5 cm, several applications will be applied on adjacent areas, until the whole lesion is covered.

Device: EmoLED; Procedure: current Standards Of Care

Interventions

EmoLED DEVICE

The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.

EmoLED Group

current Standards Of Care PROCEDURE

The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied. Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out.

EmoLED Group; SOC Group

Eligibility Criteria

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

You may qualify if:

• Subjects suffering from venous and mixed skin ulcers;
• Presence of a lesion \< 100 cm² of area and \< 1 cm in depth;
• Men and women ≥ 18 years old;
• The patient must be able to understand the aims of the clinical trial and provide informed consent in writing;
• Chronicity of the lesion: at least 8 weeks.

You may not qualify if:

• Patients who participated in clinical trials about skin ulcers healing during the previous month;
• Patients who are not able to understand the aims of the trial;
• Patients with pressure ulcers;
• Patients with diabetic foot ulcers;
• Patients with circumferential leg ulcer (due to the difficulties in analysing the pictures);
• Patients with clearly infected ulcers or with systemic infection;
• Patients with ulcers caused by critical ischemia;
• Patients with a self-harm past that can purposely alter the process of healing;
• Patients with psychiatric disorders;

Sponsors & Collaborators

• Emoled: lead

Study Sites (5)

Ospedale Briolini, ASST Bergamo EST

Gazzaniga, Bergamo, 24025, Italy

Location

Ospedale Felice Lotti

Pontedera, Pisa, 56025, Italy

Location

Geriatrics Unit, Presidio Ospedaliero di Rete San Bassiano, ULSS 7 Pedemontana

Bassano del Grappa, Vicenza, 36061, Italy

Location

Dermatology Unit AOU Policlinico Sant'Orsola - Malpighi

Bologna, 40138, Italy

Location

Dermatology Unit, Azienda Ospedaliero Universitaria Pisana, Stabilimento di S. Chiara

Pisa, 56126, Italy

Location

Related Publications (18)

• Clark RA. Cutaneous tissue repair: basic biologic considerations. I. J Am Acad Dermatol. 1985 Nov;13(5 Pt 1):701-25. doi: 10.1016/s0190-9622(85)70213-7.

  PMID: 2416789 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

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

  PMID: 9696897 BACKGROUND

• Hackam DJ, Ford HR. Cellular, biochemical, and clinical aspects of wound healing. Surg Infect (Larchmt). 2002;3 Suppl 1:S23-35. doi: 10.1089/sur.2002.3.s1-23.

  PMID: 12573037 BACKGROUND

• Calderhead (2007), The photobiological basis behind light-emetting diode (LED) phototherapy, Laser therapy

  BACKGROUND

• Beani JC, Jeanmougin M. [Narrow-band UVB therapy in psoriasis vulgaris: good practice guideline and recommendations of the French Society of Photodermatology]. Ann Dermatol Venereol. 2010 Jan;137(1):21-31. doi: 10.1016/j.annder.2009.12.004. Epub 2009 Dec 29. French.

  PMID: 20110064 BACKGROUND

• 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.

  PMID: 22081819 BACKGROUND

• 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.

  PMID: 25575297 BACKGROUND

• 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.

  PMID: 25282159 BACKGROUND

• 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

• Niemz MH (1996), Laser-tissue interactions: fundamentals and applications.

  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

• Vitse J, Bekara F, Byun S, Herlin C, Teot L. A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of Low-Level Laser Therapy on Venous Leg Ulcers. Int J Low Extrem Wounds. 2017 Mar;16(1):29-35. doi: 10.1177/1534734617690948. Epub 2017 Feb 17.

  PMID: 28682676 BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer; Leg Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Rossi Degl'Innocenti Duccio, Clinical Affairs Manager
• Organization: EMOLED SRL

d.rossi@emoled.com

+390550751960

Study Officials

• Marco Romanelli, MD

  Azienda Ospedaliero, Universitaria Pisana

  PRINCIPAL INVESTIGATOR

• Stefano Gasperini, MD

  Medical Advisor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 30, 2020
• Study Start: May 14, 2019
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after publication

Locations

IT (5)