An observational study in Cutaneous Ulcer and Trauma Injury, sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti. Completed at 4 sites in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti · Observational
The etiology of non-healing ulcers depends on both systemic and local factors. The introduction of advanced dressing, negative wound therapy and compression therapy have undoubtedly improved clinical outcomes. The principal aim of study was to demonstrate the efficacy of skin micrografts in the treatment of skin substance loss.
The principal aim of study was to evaluate the efficacy of skin micro-grafts obtained with the system of mechanical disintegration in the reconstruction of skin substance loss in the limbs.
The primary endpoint consists in evaluating, through a specific evaluation scale, the Wound Bed Score (WBS) for skin substance loss at Time 0 (T0) and 30 days after the procedure (T30) and to evaluate the increase of this score in this time frame set at 50%. The evaluation will be carried out in double blind.
The secondary endpoints instead consist in the evaluation of the Wound Surface Area Assessment to be carried out at T0 and T30.
In the evaluation of the quality of the resulting scars, through the Vancouver Scale (VS), 90 (T90) and 180 days (T180) after treatment and to evaluate the reduction of this score by 15%; on the other in the evaluation of the progress of the Visual Analogic Scale (VAS) administered to the patient at T0, 30, 90, 180.
The purpose of this minimally invasive treatment is to improve the quality of life of those affected by these injuries, avoiding the use of prolonged advanced medications and / or more invasive surgical procedures, thus speeding up healing and favoring the clinical outcome of patients.
No chemical reagents or enzymes are used for the method. There is therefore no tissue manipulation, in full compliance with the European directive 23/2004.
61 studies on the registry are indexed under Skin Ulcer; 14 are open to participants now.
Browse Skin Ulcer studies →Azienda Ospedaliero, Universitaria Ospedali Riuniti is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who attend the various regional hospitals through the emergency room or surgical clinic
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Wound Bed Score values
Percentage of patients with change of the Wound Bed Score values higher than 50%, after 30 days,
Time frame: change of baseline wound bed score values at day 30
Spontaneous re-epithelialization.
Percentage of patients with spontaneous re-epithelialization of the total wound surface, after 30 days, as assessed by Wound Surface Area Assessment
Time frame: Day 0 and Day 30
Vancouver scale
Percentage of patients with change of Vancouver scale values higher than 15%
Time frame: Day 30, Day 90 and Day 180
Ran from Oct 2017 to primary completion in Oct 2018, 12 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero, Universitaria Ospedali Riuniti