Leg Ulcers Venous Clinical Trial
— BLUROfficial title:
Multi-center Study on the Effectiveness of Treatment With a Blue Light Medical Device (EmoLED) in Reduction of the Ulcer Surface in 10 Weeks
Verified date | March 2021 |
Source | Emoled |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | December 22, 2019 |
Est. primary completion date | November 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion 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 ; - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Umberto I-Wound and Diabetic foot ambulatory | Bari | |
Italy | Barbantini Clinic | Lucca | |
Italy | Lucca Hospital | Lucca | |
Italy | Policlinico G. Martino | Messina | |
Italy | ASL Napoli 3 Sud | Naples | |
Italy | Saint Luca Clinic | Turin | |
Italy | San Lazzaro Hospital - Plastic Surgery Department | Turin |
Lead Sponsor | Collaborator |
---|---|
Emoled | Akros Bioscience, Istituto di Fisiologia Clinica CNR, Phidea Group, University of Pisa |
Italy,
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. — View Citation
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. Review. French. — View Citation
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, González-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. — View Citation
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. — View Citation
Clark RA. Cutaneous tissue repair: basic biologic considerations. I. J Am Acad Dermatol. 1985 Nov;13(5 Pt 1):701-25. Review. — View Citation
F. Petrella, Progetto SIUC (Studio Incidenza Ulcere Cutanee), 1 gennaio 2015 - 31 dicembre 2016, AIUC
Hackam DJ, Ford HR. Cellular, biochemical, and clinical aspects of wound healing. Surg Infect (Larchmt). 2002;3 Suppl 1:S23-35. Review. — View Citation
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. — View Citation
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. — View Citation
M. Fraccalvieri "Le terapie della deiscenza dell'incisione chirurgica" Ediz Minerva Medica, pag 17, Aprile 2015, Torino, Italy, ISBN 9-788877-118325
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. — View Citation
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. — View Citation
Meaume S, Dissemond J, Addala A, Vanscheidt W, Stücker 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. — View Citation
Nwomeh BC, Yager DR, Cohen IK. Physiology of the chronic wound. Clin Plast Surg. 1998 Jul;25(3):341-56. Review. — View Citation
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.
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. — View Citation
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. Review. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of Participants With Treatment-Emergent Adverse Events | Presence of any Adverse event during treatment period and after | 10 weeks treatment or in case of adverse event until the patient status return to normal | |
Secondary | Weekly Comparison of Healing Percentage | Outcomes comparison as percentage reduction of the lesion treated with EmoLED versus the lesion treated with SOC within ten weeks of the study. The measure of the outcome was calculated by the average of the medians of the weekly percentage reduction of the area, compared to the previous visit. | 10 weeks | |
Secondary | Percentage of Recovered Wounds at 10 Weeks | Time difference measured in weeks to reach the healing. The analysis was conducted deriving the Kaplan-Meyer curves from the analysis of the healing time. The K-M curves describe the probability of healing at each control time. | 10 weeks | |
Secondary | Pain Change | pre-treatment evaluation with Visual Analogic Scale (0-10 scale with 0 as no pain and 10 as extreme pain) and comparison with the same scale measured at each treatment. The result is measured by writing the averages of Week 1 and of Week 10. | Week 1 and Week 10 | |
Secondary | Event of Recidivism | At the discretion of the patient's willingness to continue to visit the study site; observation of the unhealed area(s) over the 10-week period is extended until healing or up to 20 weeks. | 20 weeks |
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