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.

Completed

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

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

Other trials in United States

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 groups in NCT01442103
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.

Sep 2011May 2012

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Wounds trials

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

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

Results posted to the registry on 8 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Silver Gel, Chronic Wounds	10	8

Primary outcome: Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.

Time frame: 4 weeks. Number. Unit: participants

Measure	Device Common Dressing n = 10
Value	8

Population analysed: Popul for the asses.of safety was incld all subjs that received at least one device and that provided data after baseline. Prim.analys:ITT, popul incld all subjs that provid.data for the prim endpoint Parameters were summ for the ITT popul using apt sum. statistics. Data described in a descriptive manner only. Efficacy endpoints were sum.by visit.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device Common Dressing	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): Small study population, 2 patients lost to follow-up.

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.

Related trials for Chronic Wounds

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
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Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
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Chronic Subdural Hematoma

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?

On the ClinicalTrials.gov record for NCT01442103.

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.