Venous Leg UlcerPhase 4CUCO-UVNCT03667937
Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers
A Phase 4 study testing CUTIMED and AQUACEL silver in people with Venous Leg Ulcer and Bacterial Infections, run by University of Malaga at 1 site in Spain.
Trial summary
This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Bacterial Infections, Chronic Ulcer of Skin of Lower Limb Nos
- What is being tested?
- CUTIMED and AQUACEL silver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2019to 30 Apr 2021
- Phase
- Phase 4
- 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
- Adult patients with chronic venous vascular ulcer located in lower limbs with signs of critical colonization, according to the criteria of Lazareth and Moore, which imply the presence of at least 3 of the following five:
- Severe pain during dressing change
- Perilesional edema.
- Local edema.
- Unpleasant smell.
- Abundant pus
- Microbial colonization higher than 100000 CFUs
Who cannot join
- Patients younger than 18 years old.
- Venous ulcer with signs of infection which requires antibiotic therapy
- Venous ulcers that do not meet Lazareth and Moore criteria
- Arterial ulcers.
- Patients with type I or type II diabetes.
- Patients with immunosuppression of any etiology or in immunosuppressive treatment or with NSAIDs.
Show all 10Show fewer
- Patients with rheumatoid arthritis in the acute phase.
- Patients with dermatitis prior to the appearance of the ulcer.
- Patients with neuropathy or lack of sensitivity of any etiology.
- Patients who, for local or systemic clinical reasons, will need to initiate antibiotic therapy.
Trial locations and contacts
1 site in 1 country.
Juan Carlos Morilla Herrera, PhD contact
Spain1 site, 1 recruiting
- Recruiting
University of Málaga
Málaga, 29071
José Miguel Morales Asencio, PhD, 0034951952833, jmmasen@uma.es
José Miguel Morales Asencio, PhD
About this study
Official title: Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers: An Open, Controlled, Randomized Study, With Blinded Endpoint (PROBE Trial): CUCO-UV Study
This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers.
Read the detailed description
Chronic wounds with torpid evolution are a real challenge for health services today. In the case of venous ulcers, it is estimated that more than 80% of these wounds may be colonized or infected by bacteria, which is associated with its chronification by delaying the healing process.
The most widespread therapeutic strategy in routine clinical practice is the use of silver dressings, due to its high antimicrobial power, although the effectiveness of these in venous ulcers is not supported by solid evidence. In addition, there are some uncertainties about the possible adverse effects of systemic absorption of silver molecules, as well as bacterial resistance to silver and the high cost associated with prolonged treatments.
In this sense, a novel method to deal with this problem is the use of dressings with high hydrophobic power, such as CUTIMED®.
- Being tested
- CUTIMED, AQUACEL silver
- Keywords
- Venous Ulcer, Leg Injuries, Bacterial Infections
- Medical subject headings
- Varicose Ulcer, Bacterial Infections, Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUTIMEDCombination product
Hydrophobic Dressing
AQUACEL silverOther
Silver Dressing
| Study group | Role | What they receive |
|---|---|---|
| CUTIMED | Experimental | After an initial culture to determine the bacterial load by smear, we will proceed to the cure of the ulcer by washing the area with physiological saline solution and to mechanical debridement, if necessary, to apply the CUTIMED dressing. It will be covered with a secondary gauze dressing and a double compression bandage with a normal crepe bandage.
If the wound exudate decreases, or the removal of the dressing is difficult, it will be changed to CUTIMED gel; in case of abundant exudate, the use of alginate without silver will be allowed for the treatment, because it is neutral with the bacterial load, placed on the CUTIMED dressing.
Primary and secondary end-points will be measured at baseline and at 4, 8 and 12 weeks, except quality of life (only baseline and at 12 weeks). Receives: Combination Product: CUTIMED |
| AQUACEL silver | Active comparator | After an initial culture to determine the bacterial load by smear, we will proceed to the cure of the ulcer by washing the area with physiological saline solution and to mechanical debridement, if necessary, to apply Aquacel-Ag. It will be covered with a secondary gauze dressing and a double compression bandage with a normal crepe bandage.
Primary and secondary end-points will be measured at baseline and at 4, 8 and 12 weeks, except quality of life (only baseline and at 12 weeks). Receives: Other: AQUACEL silver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microorganisms' Colonization Level
Evaluated by Reverse Transcription Polymerase Chain Reaction (RT-PCR) identification technique and quantified in colony forming units (CFU) and in ng of bacterial DNA per μL of vascular ulcer exudate.
Measured: Change from baseline, at 4, 8 and 12 weeks
Secondary outcomes (6)
Pain due to the wound
Measured with tha Visual Analogue Scale (VAS): Minimum score=1; Maximum score=10.
Measured: Change from baseline at 4, 8 and 12 weeks
Wound size (wound reduction percentage)
It will be evaluated by planimetry with PictZar 7.5 software
Measured: Baseline, 4, 8 and 12 weeks
Healing time
This outcome will be measure by number of days until healing
Measured: Change from baseline at 4, 8 and 12 weeks
Complete wound healing (Resvech 2.0 score)
Complete healing will be considered with a 0 score in the fourth dimension of the Resvech 2.0 scale
Measured: Change from baseline at 4, 8 and 12 weeks
Patient quality of life
Measured with Charing Cross Venous Ulcer Questionnaire (CCVUQ), in its Spanish version. The CCVUQ is composed of 22 items that determine four important dimensions for health: the social function, domestic activities, the aesthetic dimension and the emotional state. Each item should be assessed using a Likert scale with a punctuation from 1 to 5. In their interpretation, lower scores indicate a better quality of life.
Measured: Change from baseline at 12 weeks
Adverse Events
Adverse events related with the treatment, referred by patients, caregivers or health professionals
Measured: Change from baseline at 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start15 May 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Venous Leg UlcerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- BSN Medical GmbH, Andalusian Health Service
- Responsible party
- Principal investigator, JOSE MIGUEL MORALES ASENCIO, University of Malaga
- Investigators
- José Miguel Morales Asencio, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667937
- Sponsor's protocol ID
- CUCO-UV
- Acronym
- CUCO-UV
- Status last verified
- Mar 2020
- First submitted
- 24 May 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez de la Torre H, Quintana-Lorenzo ML, Perdomo-Perez E, Verdu J. Correlation between health-related quality of life and venous leg ulcer's severity and characteristics: a cross-sectional study. Int Wound J. 2017 Apr;14(2):360-368. doi: 10.1111/iwj.12610. Epub 2016 Apr 25.
PubMed 27112627Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press. 1992 Aug;1(2):113-9. doi: 10.3109/08037059209077502.
PubMed 1366259Lazareth I, Ourabah Z, Senet P, Cartier H, Sauvadet A, Bohbot S. Evaluation of a new silver foam dressing in patients with critically colonised venous leg ulcers. J Wound Care. 2007 Mar;16(3):129-32. doi: 10.12968/jowc.2007.16.3.27015.
PubMed 17385590Moore K, Hall V, Paull A, Morris T, Brown S, McCulloch D, Richardson MC, Harding KG. Surface bacteriology of venous leg ulcers and healing outcome. J Clin Pathol. 2010 Sep;63(9):830-4. doi: 10.1136/jcp.2010.077032. Epub 2010 Jul 29.
PubMed 20671048Moore MF. Prospective, Descriptive Study of Critically Colonized Venous Leg Ulcers Managed With Silver Containing Absorbent Dressings and Compression. J Am Coll Clin Wound Spec. 2014 Sep 16;5(2):36-9. doi: 10.1016/j.jccw.2014.08.002. eCollection 2013 Aug.
PubMed 26199888Pugliese DJ. Infection in Venous Leg Ulcers: Considerations for Optimal Management in the Elderly. Drugs Aging. 2016 Feb;33(2):87-96. doi: 10.1007/s40266-016-0343-8.
PubMed 26833351Totty JP, Bua N, Smith GE, Harwood AE, Carradice D, Wallace T, Chetter IC. Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: a systematic review. J Wound Care. 2017 Mar 2;26(3):107-114. doi: 10.12968/jowc.2017.26.3.107.
PubMed 28277989Wendelken ME, Berg WT, Lichtenstein P, Markowitz L, Comfort C, Alvarez OM. Wounds measured from digital photographs using photodigital planimetry software: validation and rater reliability. Wounds. 2011 Sep;23(9):267-75.
PubMed 25879267González-Consuegra, R.V., Verdú, J., 2010. Proceso de adaptación al castellano del Charing Cross Venous Ulcer Questionnaire (CCVUQ) para medir la calidad de vida relacionada con la salud en pacientes con úlceras venosas. Gerokomos 21, 80-87
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers: An Open, Controlled, Randomized Study, With Blinded Endpoint (PROBE Trial): CUCO-UV Study
- ClinicalTrials.gov ID
- NCT03667937
- Acronym / sponsor ID
- CUCO-UV / CUCO-UV
- Keywords
- Venous Ulcer, Leg Injuries, Bacterial Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- BSN Medical GmbH, Andalusian Health Service
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 12 Sep 2018 (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.
This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers.
Detailed description
Chronic wounds with torpid evolution are a real challenge for health services today. In the case of venous ulcers, it is estimated that more than 80% of these wounds may be colonized or infected by bacteria, which is associated with its chronification by delaying the healing process.
The most widespread therapeutic strategy in routine clinical practice is the use of silver dressings, due to its high antimicrobial power, although the effectiveness of these in venous ulcers is not supported by solid evidence. In addition, there are some uncertainties about the possible adverse effects of systemic absorption of silver molecules, as well as bacterial resistance to silver and the high cost associated with prolonged treatments.
In this sense, a novel method to deal with this problem is the use of dressings with high hydrophobic power, such as CUTIMED®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CUTIMED | Experimental | Combination Product: CUTIMEDAfter an initial culture to determine the bacterial load by smear, we will proceed to the cure of the ulcer by washing the area with physiological saline solution and to mechanical debridement, if necessary, to apply the CUTIMED dressing. It will be covered with a secondary gauze dressing and a double compression bandage with a normal crepe bandage. If the wound exudate decreases, or the removal of the dressing is difficult, it will be changed to CUTIMED gel; in case of abundant exudate, the use of alginate without silver will be allowed for the treatment, because it is neutral with the bacterial load, placed on the CUTIMED dressing. Primary and secondary end-points will be measured at baseline and at 4, 8 and 12 weeks, except quality of life (only baseline and at 12 weeks). |
| AQUACEL silver | Active comparator | Other: AQUACEL silverAfter an initial culture to determine the bacterial load by smear, we will proceed to the cure of the ulcer by washing the area with physiological saline solution and to mechanical debridement, if necessary, to apply Aquacel-Ag. It will be covered with a secondary gauze dressing and a double compression bandage with a normal crepe bandage. Primary and secondary end-points will be measured at baseline and at 4, 8 and 12 weeks, except quality of life (only baseline and at 12 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients with chronic venous vascular ulcer located in lower limbs with signs of critical colonization, according to the criteria of Lazareth and Moore, which imply the presence of at least 3 of the following five:
- Severe pain during dressing change
- Perilesional edema.
- Local edema.
- Unpleasant smell.
Key exclusion criteria (10 listed)
- Patients younger than 18 years old.
- Venous ulcer with signs of infection which requires antibiotic therapy
- Venous ulcers that do not meet Lazareth and Moore criteria
- Arterial ulcers.
- Patients with type I or type II diabetes.
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 |
|---|---|---|
| CUTIMEDHydrophobic Dressing | Combination product | CUTIMED |
| AQUACEL silverSilver Dressing | Other | AQUACEL silver |
Primary outcome
Microorganisms' Colonization Level
Time frame: Change from baseline, at 4, 8 and 12 weeks
Evaluated by Reverse Transcription Polymerase Chain Reaction (RT-PCR) identification technique and quantified in colony forming units (CFU) and in ng of bacterial DNA per μL of vascular ulcer exudate.
6 secondary outcomes
Pain due to the wound
Time frame: Change from baseline at 4, 8 and 12 weeks
Wound size (wound reduction percentage)
Time frame: Baseline, 4, 8 and 12 weeks
Healing time
Time frame: Change from baseline at 4, 8 and 12 weeks
Complete wound healing (Resvech 2.0 score)
Time frame: Change from baseline at 4, 8 and 12 weeks
Patient quality of life
Time frame: Change from baseline at 12 weeks
Adverse Events
Time frame: Change from baseline at 4, 8 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 27112627Gonzalez de la Torre H, Quintana-Lorenzo ML, Perdomo-Perez E, Verdu J. Correlation between health-related quality of life and venous leg ulcer's severity and characteristics: a cross-sectional study. Int Wound J. 2017 Apr;14(2):360-368. doi: 10.1111/iwj.12610. Epub 2016 Apr 25.
- Background: PubMed 1366259Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press. 1992 Aug;1(2):113-9. doi: 10.3109/08037059209077502.
- Background: PubMed 17385590Lazareth I, Ourabah Z, Senet P, Cartier H, Sauvadet A, Bohbot S. Evaluation of a new silver foam dressing in patients with critically colonised venous leg ulcers. J Wound Care. 2007 Mar;16(3):129-32. doi: 10.12968/jowc.2007.16.3.27015.
- Background: PubMed 20671048Moore K, Hall V, Paull A, Morris T, Brown S, McCulloch D, Richardson MC, Harding KG. Surface bacteriology of venous leg ulcers and healing outcome. J Clin Pathol. 2010 Sep;63(9):830-4. doi: 10.1136/jcp.2010.077032. Epub 2010 Jul 29.
- Background: PubMed 26199888Moore MF. Prospective, Descriptive Study of Critically Colonized Venous Leg Ulcers Managed With Silver Containing Absorbent Dressings and Compression. J Am Coll Clin Wound Spec. 2014 Sep 16;5(2):36-9. doi: 10.1016/j.jccw.2014.08.002. eCollection 2013 Aug.
- Background: PubMed 26833351Pugliese DJ. Infection in Venous Leg Ulcers: Considerations for Optimal Management in the Elderly. Drugs Aging. 2016 Feb;33(2):87-96. doi: 10.1007/s40266-016-0343-8.
- Background: PubMed 28277989Totty JP, Bua N, Smith GE, Harwood AE, Carradice D, Wallace T, Chetter IC. Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: a systematic review. J Wound Care. 2017 Mar 2;26(3):107-114. doi: 10.12968/jowc.2017.26.3.107.
- Background: PubMed 25879267Wendelken ME, Berg WT, Lichtenstein P, Markowitz L, Comfort C, Alvarez OM. Wounds measured from digital photographs using photodigital planimetry software: validation and rater reliability. Wounds. 2011 Sep;23(9):267-75.
- BackgroundGonzález-Consuegra, R.V., Verdú, J., 2010. Proceso de adaptación al castellano del Charing Cross Venous Ulcer Questionnaire (CCVUQ) para medir la calidad de vida relacionada con la salud en pacientes con úlceras venosas. Gerokomos 21, 80-87
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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.
Juan Carlos Morilla Herrera, PhD contact
José Miguel Morales Asencio, PhD principal investigator
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CUTIMED and AQUACEL silver in people with Venous Leg Ulcer and Bacterial Infections, run by University of Malaga 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 7 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: status not confirmed, as of the sponsor's last update on 25 Mar 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 José Miguel Morales Asencio, PhD (0034951952833, jmmasen@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microorganisms' Colonization Level (time frame: Change from baseline, at 4, 8 and 12 weeks). 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 NCT03667937, which also lists 9 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 25 Mar 2020.