Hard-to-heal WoundsREOXNCT03934671
Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing
A study testing Antioxidant dressing (active product) in people with Hard-to-heal Wounds, run by University of Jaén at 1 site in Spain.
Trial summary
The aim of this study is to compare the effect of antioxidant dressing (active product) on chronic wound healing with the use of non-active wound dressing for healing in a moist environment (standard clinical practice) in patients with hard-to-heal wounds Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hard-to-heal Wounds
- What is being tested?
- Antioxidant dressing (active product)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2019to 30 Oct 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age.
- Patients with leg ulcers (venous, ischemic, traumatic or diabetic foot ulcer).
- Patients with dehisced surgical wounds healing by second intention.
- Patients with pressure ulcers.
- Wound area between 1 and 250 cm2.
Who cannot join
- Systemic inflammatory disease or oncological disease.
- Wounds with clinical signs of infection.
- Terminal situation (life expectancy less than 6 months).
- Ulcers from other etiologies: tumours, infectious.
- Wounds treated with negative pressure therapy.
- Pregnancy.
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- History of sensitivity or allergy to any of the components of the study dressing.
- In addition, criteria for withdrawal from the study will be considered:
- Worsening of the wound according to the clinical judgment of the professional (appearance of clinical signs of infection or others).
- Appearance of allergies or hypersensitivity to the dressing.
- Death.
- Hospital admission that interrupts or complicates the continuity of care in the Nursing Consultation.
- Transfer to another Health District where there can be no continuity of care with the active dressing.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the effect of antioxidant dressing (active product) on chronic wound healing with the use of non-active wound dressing for healing in a moist environment (standard clinical practice) in patients with hard-to-heal wounds
- Conditions
- Hard-to-heal Wounds
- Being tested
- Antioxidant dressing (active product), Usual care dressing that create a moist environment (standard clinical practice)
- Keywords
- Chronic wound, Wound healing, Hard-to-heal wounds, Antioxidant dressing, Oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidant dressing (active product)Device
Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary.
Device: Reoxcare®
Usual care dressing that create a moist environment (standard clinical practice)Device
Usual care dressing; moist environment dressing chosen from the study centres' formulary (hydrocolloid, alginate, polyurethane foam dressings, silver dressings). Compression bandage if necessary
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant dressing (active product) | Experimental | Not described Receives: Device: Antioxidant dressing (active product) |
| Usual care dressing (standard clinical practice) | Active comparator | Not described Receives: Device: Usual care dressing that create a moist environment (standard clinical practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring
The RESVECH 2.0 is a scale for monitoring the cicatrization of the wound. It has 6 items: size of the lesion, depth/tissue concerned, edges, type of tissue in the wound bed, exudate, infection/inflammation. The scale is scored numerically and can score ranging from 0 to 35 points, wound healed and the worst possible lesion respectively
Measured: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Wound size reduction
Difference in wound area between first and last dressing
Measured: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Secondary outcomes (5)
Time required to achieve 50% reduction in wound size
Measured: Change from baseline to 8 weeks of follow up
Time to removal of non-viable tissue from wound bed
Measured: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Number of completely healed wounds
Measured: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Pain level
The visual analogue scale (VAS) is commonly used as the outcome measure for patient´s pain. It is usually presented as a 100-mm horizontal line on which pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Measured: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Area of wound with bacterial load
clinical signs of infection and/or measurement of surfaces with bacteria
Measured: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start2 Sep 2019
- Primary completion31 Jan 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hard-to-heal WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Collaborators
- Histocell, S.L., Andalusian Health Service: District Poniente Almería., Andalusian Health Service: District Jaén, Andalusian Health Service: District Jaén-Nordeste, Andalusian Health Service: Health Management Area Este of Málaga-Axarquía.
- Responsible party
- Principal investigator, Inés María Comino-Sanz, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934671
- Sponsor's protocol ID
- TD-REOX-2019
- Acronym
- REOX
- Status last verified
- Dec 2021
- First submitted
- 24 Apr 2019
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Castro B, Bastida FD, Segovia T, Lopez Casanova P, Soldevilla JJ, Verdu-Soriano J. The use of an antioxidant dressing on hard-to-heal wounds: a multicentre, prospective case series. J Wound Care. 2017 Dec 2;26(12):742-750. doi: 10.12968/jowc.2017.26.12.742.
PubMed 29244974Castro B, Palomares T, Azcoitia I, Bastida F, del Olmo M, Soldevilla JJ, Alonso-Varona A. Development and preclinical evaluation of a new galactomannan-based dressing with antioxidant properties for wound healing. Histol Histopathol. 2015 Dec;30(12):1499-512. doi: 10.14670/HH-11-646. Epub 2015 Jul 3.
PubMed 26140672Comino-Sanz IM, Lopez-Franco MD, Castro B, Pancorbo-Hidalgo PL. Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial. Trials. 2020 Jun 8;21(1):505. doi: 10.1186/s13063-020-04445-5.
PubMed 32513260
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing
- ClinicalTrials.gov ID
- NCT03934671
- Acronym / sponsor ID
- REOX / TD-REOX-2019
- Conditions
- Hard-to-heal Wounds
- Keywords
- Chronic wound, Wound healing, Hard-to-heal wounds, Antioxidant dressing, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Collaborators
- Histocell, S.L., Andalusian Health Service: District Poniente Almería., Andalusian Health Service: District Jaén, Andalusian Health Service: District Jaén-Nordeste, Andalusian Health Service: Health Management Area Este of Málaga-Axarquía.
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the effect of antioxidant dressing (active product) on chronic wound healing with the use of non-active wound dressing for healing in a moist environment (standard clinical practice) in patients with hard-to-heal wounds
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant dressing (active product) | Experimental | Device: Antioxidant dressing (active product) |
| Usual care dressing (standard clinical practice) | Active comparator | Device: Usual care dressing that create a moist environment (standard clinical practice) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18 years of age.
- Patients with leg ulcers (venous, ischemic, traumatic or diabetic foot ulcer).
- Patients with dehisced surgical wounds healing by second intention.
- Patients with pressure ulcers.
- Wound area between 1 and 250 cm2.
Key exclusion criteria (13 listed)
- Systemic inflammatory disease or oncological disease.
- Wounds with clinical signs of infection.
- Terminal situation (life expectancy less than 6 months).
- Ulcers from other etiologies: tumours, infectious.
- Wounds treated with negative pressure therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidant dressing (active product)Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary. Device: Reoxcare® | Device | Antioxidant dressing (active product) |
| Usual care dressing that create a moist environment (standard clinical practice)Usual care dressing; moist environment dressing chosen from the study centres' formulary (hydrocolloid, alginate, polyurethane foam dressings, silver dressings). Compression bandage if necessary | Device | Usual care dressing (standard clinical practice) |
Primary outcome
Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring
Time frame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
The RESVECH 2.0 is a scale for monitoring the cicatrization of the wound. It has 6 items: size of the lesion, depth/tissue concerned, edges, type of tissue in the wound bed, exudate, infection/inflammation. The scale is scored numerically and can score ranging from 0 to 35 points, wound healed and the worst possible lesion respectively
Wound size reduction
Time frame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Difference in wound area between first and last dressing
5 secondary outcomes
Time required to achieve 50% reduction in wound size
Time frame: Change from baseline to 8 weeks of follow up
Time to removal of non-viable tissue from wound bed
Time frame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Number of completely healed wounds
Time frame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Pain level
Time frame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Area of wound with bacterial load
Time frame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Background: PubMed 29244974Castro B, Bastida FD, Segovia T, Lopez Casanova P, Soldevilla JJ, Verdu-Soriano J. The use of an antioxidant dressing on hard-to-heal wounds: a multicentre, prospective case series. J Wound Care. 2017 Dec 2;26(12):742-750. doi: 10.12968/jowc.2017.26.12.742.
- Background: PubMed 26140672Castro B, Palomares T, Azcoitia I, Bastida F, del Olmo M, Soldevilla JJ, Alonso-Varona A. Development and preclinical evaluation of a new galactomannan-based dressing with antioxidant properties for wound healing. Histol Histopathol. 2015 Dec;30(12):1499-512. doi: 10.14670/HH-11-646. Epub 2015 Jul 3.
- Background: PubMed 32513260Comino-Sanz IM, Lopez-Franco MD, Castro B, Pancorbo-Hidalgo PL. Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial. Trials. 2020 Jun 8;21(1):505. doi: 10.1186/s13063-020-04445-5.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidant dressing (active product) in people with Hard-to-heal Wounds, run by University of Jaén at 1 site in Spain.
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 5 inclusion and 13 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 21 Dec 2021. 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 Spain. 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?
Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring (time frame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week). The study lists 2 primary outcomes in all. 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 NCT03934671, which also lists 3 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 21 Dec 2021.