Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05181644 |
| Other study ID # |
EmoLED_004 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 22, 2022 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Emoled |
| Contact |
Duccio Rossi Degl'Innocenti |
| Phone |
0550751981 |
| Email |
d.rossi[@]emoled.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The present clinical study aims to compare, in the two groups of patients with acral ulcers,
the reparative process of the injured area, the evaluation of the healing time (with
"healing" interpreted as the complete re-epithelization of the wound) and the perception of
pain through NRS scale.
Description:
This clinical study will be a prospective, randomized controlled study, with the commercial
objective of assessing the clinical effectiveness of a portable battery powered device that
uses blue LED.
This clinical study aims to compare the existing standard treatment for acral ulcers in
patients suffering from scleroderma, to a protocol that provides for the administration of
the EmoLED treatment for 16 consecutive weeks in addition to the conventional therapy.
The objective is to determine any differences in outcome between the two groups considered
and whether the therapy of the treatment group is a valid alternative to the current therapy
in terms of support for the reparative process, speed of healing and pain reduction.
The study protocol also establishes a follow-up period of 4 weeks. If the injury has not
healed within the 16 weeks of treatment, the patient will return to the investigator centre
for the usual dressing, and the evolution of the injury will be observed for 4 weeks. If the
recovery occurs within the 16 weeks of treatment, the patient will return to the investigator
centre 4 weeks after recovery, for a check-up, during which the condition of the healed skin
area and the presence of any relapses will be evaluated.
In this clinical study, patients with systemic sclerosis with at least one ulcerative lesion
on the upper limbs' fingers will be enrolled. In case the patient has more than one lesion,
only one will be selected for the study; it will be the one that, in the opinion of the
doctor, allows a better recording of data (image acquisition).
The population subject matter of the study is largely representative of the target
population, as there are no particular exclusion criteria and the center involved is a
structure of excellence in the treatment of acral ulcers of sclerodermal origin.
Scleroderma, or systemic sclerosis, is a chronic systemic disease with autoimmune
pathogenesis, characterized by skin and internal organs fibrosis caused by an altered
functionality of fibroblasts, the presence of perivascular inflammatory infiltration and
small vessel alterations and immune system abnormalities.
The incidence of scleroderma is estimated in about twenty cases per million inhabitants per
year. The peak age range for the onset of this disease is between 45 and 65 years and, as
often observed in autoimmune diseases, women are more frequently affected with a ratio of
4.5:1.
Scleroderma begins in most cases with the Raynaud's phenomenon, consisting in the change of
colour of the extremities, which become initially pale, then cyanotic and finally red.
The most characteristic sign of scleroderma is the thickening of the skin, that can be found
at the level of the hands, which can meet a progressive deformity in fingers bending, and
then also at the level of the wrists, forearms, face and trunk.
There are still no drugs that can cure scleroderma. The treatments used, therefore, aim to
contain the symptoms and to avoid/delay the complications of the disease. The most commonly
used drugs include vasodilators, pro-kinetic drugs, antiarrhythmics and immunosuppressants to
treat the various complications.
Digital ulcers represent a complication that affects about half of patients with systemic
sclerosis. Digital ulcers are mainly the consequence of vascular phenomena typical of the
disease (Raynaud phenomenon and endothelial damage) or of its fibrotic evolution (skin
sclerosis). They are mainly located at the extremities where peripheral vascular phenomena
are more evident, at the level of the areas where the skin is most subjected to traction
(e.g. the elbows), or in the areas affected by calcinosis. Ulcerations of the knuckles and
fingertips are frequent.
Digital ulcers often develop a chronic trend over time, they have a slow healing, they are
intensely painful and can lead to a severe functional limitation, compromising the personal
and professional quality of life of the affected person, so much so that it represents one of
the most important complications from this point of view, perceived by patients as seriously
disabling. This type of ulcers can also lead to infectious complications (osteomyelitis,
sepsis of the surrounding soft tissues) that in the most serious cases lead to the necrosis
of the local tissue resulting in the amputation of the digital phalanges.
Factors to consider in assessing the type of the ulcer include location and size, margins and
edges, wound bed, degree of moisture (exudate), edema (local or diffused), pain assessment
and degree of infection. From these factors we can distinguish three types of ulcers:
superficial, intermediate and deep. The management of a digital ulcer is particularly complex
and may involve a local therapy, a systemic therapeutic approach, or a combined therapy.
