- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442103
Clinical Utility of a New Silver Gel for Use on Chronic Wounds
March 15, 2016 updated by: Molnlycke Health Care AB
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Augusta, Georgia, United States, 30909
- Joseph M. Still Research Foundation, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Device, dressing
Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infection Assessment
Time Frame: 4 weekks
|
Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.
|
4 weekks
|
Pain Upon Application of Investigational Product.
Time Frame: 4 weeks
|
VAS pain scale will be used to measuring pain at each dressing change.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zaheed Hassan, MD, Josepth M. Still Research Foundation, Augusta, Georgia, US
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (ACTUAL)
April 1, 2012
Study Completion (ACTUAL)
May 1, 2012
Study Registration Dates
First Submitted
September 13, 2011
First Submitted That Met QC Criteria
September 26, 2011
First Posted (ESTIMATE)
September 28, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
April 14, 2016
Last Update Submitted That Met QC Criteria
March 15, 2016
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ngel Ag 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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