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Burn InjuriesHIFNCT02870439

Testing an Innovative Biomarker: Expression of HIF-1α and Its Isoforms in the Blood and Skin Tissue of Major Burns

A study testing Blood drawn in people with Burn Injuries, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Burn injury with full-thickness skin damage that encompass large body surface areas can induce local and systemic perturbations that are costly in terms of human suffering as well as in strains on the health care system. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Burn Injuries
What is being tested?
Blood drawn
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteFrance
Study dates
Oct 2012to Oct 2017
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with burn wounds

Who cannot join

  • Patient with wounds coming from electrical or chemical burns
  • Patient undergoing long term corticotherapy

Trial locations and contacts

1 site in 1 country.

Aurélie HAUTIER, MD contact

aurelie.hautier@ap-hm.fr

France1 site, 1 recruiting
  • Assistance Publique Hôpitaux de Marseille

    Marseille, 13354

    Aurélie HAUTIER, MD, aurelie.hautier@ap-hm.fr

    Recruiting

Other trials in France

About this study

Burn injury with full-thickness skin damage that encompass large body surface areas can induce local and systemic perturbations that are costly in terms of human suffering as well as in strains on the health care system. Characterization of new major molecular biomarkers involved in this process creates significant diagnostic and therapeutic challenges.

Hypoxia-inducible factor-1 α (HIF-1 α) is a ubiquitously expressed heterodimeric transcription factor comprising an α and a β subunit. It was shown that under normoxic conditions, the HIF-1α subunit is ubiquitinated and degraded, whereas under hypoxic conditions, HIF-1α accumulates, dimerizes with HIF-1β, and activates the transcription of a spectrum of target genes encoding multiple angiogenic growth factors and cytokines of potential importance in wound healing. Seven isoforms of HIF-1α issued from alternative splicing have been identified.

Read more

The importance of HIF-1α in wound healing in animal models has been suggested by several studies. Indeed, diminished HIF-1 levels and activity have been documented in conditions of impaired wound healing. The literature review shows a marked reduction of HIF-1α levels in mice in case of burn wound skin that in the case of excisional cutaneous wound. Other studies have shown that the expression of HIF-1α was correlated with the extent and depth of the burns.

This study aims to improve the knowledge on the pathophysiological factors involved in the field of wound healing. The assumptions are based on results of studies done on mice, and this work aims to document these findings in humans.

Objective

The main objective of the study is to compare the variations of expression of HIF-1α measured in blood and skin tissue samples in three groups:

  • Subjects with major burn wounds involving more than 20% of the total body surface area;
  • Subjects with burn wounds smaller than 5% of total body surface area;
  • Subjects with a skin wound after a surgical procedure requiring a skin resection.

Secondary objectives are to compare the expression levels of HIF-1α locally at the burn site to those observed in blood, to evaluate the expression of growth factors produced by HIF-1α target genes (VEGF and EPO) or playing a central role in the healing process (TGF-β1), and to assess the correlation between the expression of HIF-1α and the kinetics of wound healing of the subject rated by evaluation of time of donor sites complete epithelialization.

Material and Methods

We propose to create three groups:

  • 15 patients with extensive third degree burns involving more than 20% of the total body surface area;
  • 15 patients with less extensive third degree burns, involving less than 5% of body surface area;
  • 15 patients with post-surgical wounds with skin resection. Skin and tissue specimens will be collected three times: day 0, 7 and 14 from burned patients (with more than 20% of the total body surface area and less than 5% of body surface area). Samples of skin tissue will be collected within the skin resection from patients with post-surgical wounds at day 0, blood samples will be collected at day 0 and 14.
Conditions
Burn Injuries
Being tested
Blood drawn
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood drawnOther

Study groups in NCT02870439
Study groupRoleWhat they receive
patients with at least 20% of wounded burns bodyExperimentalNot described
Receives: Other: Blood drawn
patients with at least 5% of wounded burns bodyExperimentalNot described
Receives: Other: Blood drawn
patients with post-surgical wounds with skin resectionExperimentalNot described
Receives: Other: Blood drawn

What is being measured

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

  1. percentage of the variations of expression of HIF-1α

    Measured: 14 days

Timeline

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

  1. First posted17 Aug 2016 (estimated)
  2. Study startOct 2012
  3. Primary completionOct 2016 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02870439
Sponsor's protocol ID
2012-23
Other IDs
2012-A00786-37
Acronym
HIF
Status last verified
Aug 2016
First submitted
12 Aug 2016
Last updated
17 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood drawn in people with Burn Injuries, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

Results are not available in the source record.

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

Contact Aurélie HAUTIER, MD (aurelie.hautier@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of the variations of expression of HIF-1α (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.

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