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Cutaneous UlcerMG-1NCT04030832

Reconstruction of Skin Substance Loss With "Micro-grafts" Obtained by Mechanical Disintegration

An observational study of Cutaneous Ulcer and Trauma Injury, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cutaneous Ulcer, Trauma Injury
How many people
70 participants
Where
4 sitesItaly
Study dates
1 Oct 2017to 30 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who attend the various regional hospitals through the emergency room or surgical clinic

Who may be able to join

  • Full-thickness skin loss from a minimum size of 3x3 cm (9cm2) to a maximum size of 5x5 cm (25cm2);
  • Loss of substance caused by abrasive-contusive traumas (loss of full-thickness skin substance) or by thermal burn (deep degree II), present for at least 15 days;
  • Absence of clinical signs of infection assessed by two culture swabs performed at T0 (pre and post debridement);
  • Pre-operative inflammatory index (VES, PCR) and b-hcg negative;
  • Absence of exposure of osteo-cartilaginous structures, of noble structures (major arterial vessels, major nerve trunks, tendons without paratenon);
  • Specific written informed consent

Who cannot join

  • Smoking patients (≥ 10 cigarettes / day);
  • Patients with type I or type II diabetes mellitus:
  • Patients suffering vascular trophic ulcers;
  • Patients with loss of substance at the level of the fingers and toes;
  • Patients with loss of substance of the foot and the yarrow region;
  • Patients with oncological pathologies in progress or in remission;
Show all 10Show fewer
  • Patients in therapy with immunosuppressive and corticosteroid drugs, anticoagulants, antiplatelet agents;
  • Patients with autoimmune diseases including connectivitis;
  • Patients with congenital, acquired and metabolic immunodeficiencies;
  • Pregnant patients (ascertained with β-HCG) and breastfeeding.

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Azienda Ospedaliera Universitaria Ospedali Riuniti

    Ancona, AN, 60126

  • IRCCS Policlinico San Donato

    Milan, MI

  • Università degli Studi di Roma "La Sapienza"

    Roma

  • Università degli Studi di Udine

    Udine, UD

Other trials in Italy

About this study

Official title: Reconstruction of Skin Substance Loss With Method of "Micro-grafts" Obtained by Mechanical Disintegration: Preliminary Study

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.

Read the detailed description

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.

Medical subject headings
Skin Ulcer, Accidental Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wound Bed Score values

    Percentage of patients with change of the Wound Bed Score values higher than 50%, after 30 days,

    Measured: change of baseline wound bed score values at day 30

Secondary outcomes (2)

  1. 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

    Measured: Day 0 and Day 30

  2. Vancouver scale

    Percentage of patients with change of Vancouver scale values higher than 15%

    Measured: Day 30, Day 90 and Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2019
  2. Study start1 Oct 2017
  3. Primary completion1 Oct 2018
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04030832
Sponsor's protocol ID
MICROINNESTI-1
Acronym
MG-1
Status last verified
Jul 2019
First submitted
17 Jul 2019
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Greaves NS, Ashcroft KJ, Baguneid M, Bayat A. Current understanding of molecular and cellular mechanisms in fibroplasia and angiogenesis during acute wound healing. J Dermatol Sci. 2013 Dec;72(3):206-17. doi: 10.1016/j.jdermsci.2013.07.008. Epub 2013 Jul 30.

    PubMed 23958517

  • Trovato L, Monti M, Del Fante C, Cervio M, Lampinen M, Ambrosio L, Redi CA, Perotti C, Kankuri E, Ambrosio G, Rodriguez Y Baena R, Pirozzi G, Graziano A. A New Medical Device Rigeneracons Allows to Obtain Viable Micro-Grafts From Mechanical Disaggregation of Human Tissues. J Cell Physiol. 2015 Oct;230(10):2299-303. doi: 10.1002/jcp.24973.

    PubMed 25728337

  • Marcarelli M, Trovato L, Novarese E, Riccio M, Graziano A. Rigenera protocol in the treatment of surgical wound dehiscence. Int Wound J. 2017 Feb;14(1):277-281. doi: 10.1111/iwj.12601. Epub 2016 Apr 29.

    PubMed 27126653

  • Baglioni E, Trovato L, Marcarelli M, Frenello A, Bocchiotti MA. Treatment of Oncological Post-surgical Wound Dehiscence with Autologous Skin Micrografts. Anticancer Res. 2016 Mar;36(3):975-9.

    PubMed 26976986

  • Svolacchia F, De Francesco F, Trovato L, Graziano A, Ferraro GA. An innovative regenerative treatment of scars with dermal micrografts. J Cosmet Dermatol. 2016 Sep;15(3):245-53. doi: 10.1111/jocd.12212. Epub 2016 Jan 30.

    PubMed 26825041

  • De Francesco F, Graziano A, Trovato L, Ceccarelli G, Romano M, Marcarelli M, Cusella De Angelis GM, Cillo U, Riccio M, Ferraro GA. A Regenerative Approach with Dermal Micrografts in the Treatment of Chronic Ulcers. Stem Cell Rev Rep. 2017 Feb;13(1):139-148. doi: 10.1007/s12015-016-9692-2.

    PubMed 27738884

  • Falanga V, Saap LJ, Ozonoff A. Wound bed score and its correlation with healing of chronic wounds. Dermatol Ther. 2006 Nov-Dec;19(6):383-90. doi: 10.1111/j.1529-8019.2006.00096.x.

    PubMed 17199681

  • Qi X, Ding L, Huang W, Wen B, Guo X, Zhang J. An improved automated type-based method for area assessment of wound surface. Wound Repair Regen. 2017 Jan;25(1):150-158. doi: 10.1111/wrr.12495. Epub 2017 Jan 25.

    PubMed 27859908

  • Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.

    PubMed 8537427

  • Jimi S, Kimura M, De Francesco F, Riccio M, Hara S, Ohjimi H. Acceleration Mechanisms of Skin Wound Healing by Autologous Micrograft in Mice. Int J Mol Sci. 2017 Aug 2;18(8):1675. doi: 10.3390/ijms18081675.

    PubMed 28767054

Questions about this trial

What is this clinical trial studying?

An observational study of Cutaneous Ulcer and Trauma Injury, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound Bed Score values (time frame: change of baseline wound bed score values at day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04030832, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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