Estrogen Deficiency Clinical Trial
— ESKITEOfficial title:
Role of Estrogens and Their Receptors in the Development of Skin Tears Evaluated in Residents of Residential Care Facilities.
Background: Skin tears (ST) or "laceration injuries" or "flap wounds" are injuries that are
often found in residents of residential care facilities (RCFs). STs were first defined by
Payne and Martin in 1993 as traumatic wounds, located mainly in the upper limbs, caused by
"shearing, friction or mechanisms combined with the consequent separation of layers of skin.
Skin Tears can cause psychological problems for the patient and represent an economic problem
with important repercussions on both the patient and the community. The etiology suggests
that the physiological changes of the skin related to old age, together with comorbidity, are
among the main risk factors for their onset.
The precise data on the phenomenon are not many, but it is estimated that STs are much more
frequent than the same pressure ulcers, observing prevalence rates in RCFs around 40%
Therefore, there are several risk factors hypothesized so far. Much evidence has correlated,
in various physiological or pathological conditions, the role of estrogens with the functions
and aging of the skin.
Objectives: The project will develop on the analysis of populations of residents from RCFs
belonging to the national territory. Two populations of residents cared in the RCF will be
recruited. A group of subjects suffering from skin tears (group A) and a control group of
subjects without skin tears (group B). The inclusion of patients in both groups will take
place through a simple randomization procedure. Group A patients will be staged according to
the STAR classification for skin tears. For each group a peripheral venous blood sample will
be taken (to measure the levels of estrone and estradiol) and a skin biopsy will be performed
in order to measure estrogen receptors (ERs) expression. A data collection sheet with
angraphic and anamnestic data will be developed to correlate the demographic and comorbidity
data with the clinical conditions of the patients and with the laboratory findings from the
sampling.
Expected results: The primary endpoint will be the correlation between serum estrogen levels,
receptor expression and the presence of skin tears. The secondary endopoint will be
Correlation between receptor structure and clinical staging of skin tears.
Future prospectives: We believe that our study may open new frontiers in the prevention and
in the management of these skin lesions.
Status | Not yet recruiting |
Enrollment | 1200 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Group A Inclusion Criteria: - Subjects of aged care facilities with skin tears Exclusion Criteria: - Patients who do not give consent; - Inability of blood sampling and / or skin biopsy Group B Inclusion Criteria: - Subjects of aged care facilities without skin tears Exclusion Criteria: - Patients who do not give consent; - Inability of blood sampling and / or skin biopsy |
Country | Name | City | State |
---|---|---|---|
Italy | University La Sapienza of Rome | Roma |
Lead Sponsor | Collaborator |
---|---|
University of Catanzaro | University of Roma La Sapienza |
Italy,
Brincat MP, Baron YM, Galea R. Estrogens and the skin. Climacteric. 2005 Jun;8(2):110-23. Review. — View Citation
El Safoury O, Rashid L, Ibrahim M. A study of androgen and estrogen receptors alpha, beta in skin tags. Indian J Dermatol. 2010;55(1):20-4. doi: 10.4103/0019-5154.60345. — View Citation
LeBlanc K, Baranoski S, Christensen D, Langemo D, Sammon MA, Edwards K, Holloway S, Gloeckner M, Williams A, Sibbald RG, Regan M. International Skin Tear Advisory Panel: a tool kit to aid in the prevention, assessment, and treatment of skin tears using a Simplified Classification System ©. Adv Skin Wound Care. 2013 Oct;26(10):459-76; quiz 477-8. doi: 10.1097/01.ASW.0000434056.04071.68. — View Citation
Payne RL, Martin ML. Defining and classifying skin tears: need for a common language. Ostomy Wound Manage. 1993 Jun;39(5):16-20, 22-4, 26. — View Citation
Payne RL, Martin ML. The epidemiology and management of skin tears in older adults. Ostomy Wound Manage. 1990 Jan-Feb;26:26-37. — View Citation
Serra R, Gallelli L, Perri P, De Francesco EM, Rigiracciolo DC, Mastroroberto P, Maggiolini M, de Franciscis S. Estrogen Receptors and Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2016 Jul;52(1):114-8. doi: 10.1016/j.ejvs.2016.04.020. Epub 2016 May 21. — View Citation
Serra R, Ielapi N, Barbetta A, de Franciscis S. Skin tears and risk factors assessment: a systematic review on evidence-based medicine. Int Wound J. 2018 Feb;15(1):38-42. doi: 10.1111/iwj.12815. Epub 2017 Oct 17. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation Between Estrogen and Skin Tears | The primary outcome measure will be the correlation between serum estrogen levels and skin receptor expression and skin tears onset. | at 1 year | |
Secondary | Correlation between patient's estrogen status and clinical staging of skin tears | The serum level of estrogens and the peripheral expression of estrogen receptor will be related to the severity of skin tears | at 2 years |
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