Chronic WoundsNCT01442103
Clinical Utility of a New Silver Gel for Use on Chronic Wounds
A study testing Normlgel Ag in people with Chronic Wounds, run by Molnlycke Health Care AB at 1 site in United States.
Trial summary
This investigation will be conducted in the US as a single-center study to evaluate in total 10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- Normlgel Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed informed consent
- Both genders with an age >18 years
- Subjects with chronic wounds < 1 year chronicity that are assessed as having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection:
- Erythema
- Edema
- Warmth
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- Increased drainage
- Foul odor
- Subject's wounds may also present with:
- presence of eschar or slough that needs to be treated prior to normal standard of care OR
- A need for topical care after debridement
- Study site to include only ONE wound to be treated
Who cannot join
- Presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection.
- Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days
- Wound > 1 year old
- Wound > 10 cm x 10 cm (l x w)
- Wound > 6 cm deep
- Use of chemical/enzymatic and biological debridement within 7 days of investigation start
Show all 13Show fewer
- Necrotizing wounds
- Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.
- Subjects with poorly controlled diabetes mellitus (as judged by the investigator).
- Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisone/day or equivalent.
- Known allergy/hypersensitivity to any of the components of the investigation products.
- Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including subjects totally confined to bed.
- Participation in other clinical investigation(s) within 1 month prior to Previously randomized to this investigation
Trial locations and contacts
1 site in 1 country.
United States1 site
Joseph M. Still Research Foundation, Inc.
Augusta, Georgia, 30909
About this study
Official title: Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds
This investigation will be conducted in the US as a single-center study to evaluate in total 10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.
Read the detailed description
Both inpatients and outpatients will be included in this study. The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
- Conditions
- Chronic Wounds
- Being tested
- Normlgel Ag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normlgel AgDevice
Normlgel Ag dressing will be changed together with planned investigation visits. Dressing changes between visits will be performed at home on Day 3 or 4 of each week by subject or caregiver and documented in a dressing log.
| Study group | Role | What they receive |
|---|---|---|
| Device, dressing | Experimental | Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound. Receives: Device: Normlgel Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.
Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.
Measured: 4 weeks
Secondary outcomes (2)
Infection Assessment
Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.
Measured: 4 weekks
Pain Upon Application of Investigational Product.
VAS pain scale will be used to measuring pain at each dressing change.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zaheed Hassan, MD, Principal investigator, Josepth M. Still Research Foundation, Augusta, Georgia, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442103
- Sponsor's protocol ID
- Ngel Ag 01
- Status last verified
- Nov 2012
- First submitted
- 13 Sep 2011
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds
- ClinicalTrials.gov ID
- NCT01442103
- Acronym / sponsor ID
- Ngel Ag 01
- Conditions
- Chronic Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Posted 8 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation will be conducted in the US as a single-center study to evaluate in total 10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.
Detailed description
Both inpatients and outpatients will be included in this study. The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device, dressing | Experimental | Device: Normlgel AgNormlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent
- Both genders with an age >18 years
- Subjects with chronic wounds < 1 year chronicity that are assessed as having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection:
- Subject's wounds may also present with:
- Study site to include only ONE wound to be treated
Key exclusion criteria (13 listed)
- Presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection.
- Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days
- Wound > 1 year old
- Wound > 10 cm x 10 cm (l x w)
- Wound > 6 cm deep
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 |
|---|---|---|
| Normlgel AgNormlgel Ag dressing will be changed together with planned investigation visits. Dressing changes between visits will be performed at home on Day 3 or 4 of each week by subject or caregiver and documented in a dressing log. | Device | Device, dressing |
Primary outcome
Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.
Time frame: 4 weeks
Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.
2 secondary outcomes
Infection Assessment
Time frame: 4 weekks
Pain Upon Application of Investigational Product.
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Zaheed Hassan, MD principal investigator
Josepth M. Still Research Foundation, Augusta, Georgia, US
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normlgel Ag in people with Chronic Wounds, run by Molnlycke Health Care AB at 1 site in United States.
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 12 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 14 Apr 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Resolution of Signs and Symptoms of Local Wound Infection/Inflammation. (time frame: 4 weeks). 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 14 Apr 2016.