Diabetic Foot UlcerNCT00389636
TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers
A study testing TheraGauze and Regranex in people with Diabetic Foot Ulcer, run by Solsys Medical LLC at 1 site in United States.
Trial summary
Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- TheraGauze and Regranex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who are 18 years old or older;
- who are diagnosed as having insulin-dependent or non-insulin-dependent diabetes mellitus (5.5% <HgBA1C<12%);
- who have foot ulcers extending through the epidermis and dermis but not with exposed tendon or bone;
- who have a diagnosis of chronic diabetic ulcer;
- who have a viable wound bed with granulation tissue as determined by bleeding following debridement;
- who have an ulcer size which is at least 1 cm2 and no greater then 16cm2;
- who have signed an informed consent form.
- who have a wound that has been present for at least 4 weeks at the time of screening.
Who cannot join
- having ulcers less than 1cm2 or greater than 16cm2 in size;
- having severe arterial disease (ankle brachial index (ABI) less than 0.65);
- having history of radiation therapy to the ulcer site;
- who use corticosteroids >10mg prednisone daily
- who use any immune suppressive, or severely immunocompromised patients;
- who have an ulcer that was of a non-diabetic pathophysiology;
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- having vasculitis, severe rheumatoid arthritis, or other collagen vascular disease;
- having malnutrition (defined by albumin <2.5 g/dL);
- having a known allergy or hypersensitivity to the components of either TheraGauze or Regranex;
- having erythema or purulence associated with a severe infection of the wound site;
- having signs and symptoms of cellulitis, osteomyelitis, necrotic or avascular ulcer beds;
- undergoing hemodialysis;
- having uncontrolled diabetes (defined as HgB A1c>12%)
- having deficient blood supply to ulcers (defined as capillary fill time >3 seconds at tips of toes)
- having Charcot's neuroarthropathy as determined by clinical and/or radiographic examination;
- having sickle cell disease;
- having exposed bone, tendon, or fascia;
- who are currently enrolled in a clinical evaluation of another investigational device or drug, or have received and investigational treatment for diabetic foot ulcers in the last 30 days;
- unable to comply with the procedures described in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers.
Read the detailed description
This study will evaluate the use of TheraGauzeT (Soluble Systems, LLC) wound dressing, a polymer hydrogel chemically impregnated into a rayon/polyester formed fabric, forming a pliable, conforming solid matrix. TheraGauze is FDA Class I exempt (regulation #21CFR, product code 5878.4022). It is hypothesized that this material will be useful for the treatment of full-thickness diabetic ulcers. It is further hypothesized that this material will enhance the action of Regranex (becaplermin) gel by providing an optimal environment for this growth factor to function. This study will observe patient outcomes following diabetic foot ulcer treatment with TheraGauze and with or without the use of Regranex.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- TheraGauze, Regranex
- Keywords
- Diabetes, Foot, Extremity, Ulcer, Wound, Gauze
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraGauzeDevice
TheraGauze
RegranexDrug
Regranex + TheraGauze
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | TheraGauze alone Receives: Device: TheraGauze |
| 2 | Active comparator | Theragauze + Regranex Receives: Drug: Regranex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of complete wound healing within 12 weeks
Time to complete wound healing within 12 weeks
Secondary outcomes (7)
Investigator's or clinician's assessment of wound quality (ulcer duration, baseline area, staging, presence of fibrin or granulation tissue)
Patient's assessment (pain, itching)
Presence of epithelialization visible on the wound surface
Occurrence of infection at the wound site
Recurrence of ulcer during the 20 week follow-up period
Adverse events (infection, cellulites, seroma, etc.)
Excess pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2008 (estimated)
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solsys Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anne Laumann, MBChB, MRCP, Principal investigator, Northwestern UniversityAdam Landsman, DPM, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389636
- Sponsor's protocol ID
- SS-0601
- Status last verified
- May 2008
- First submitted
- 18 Oct 2006
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00389636
- Acronym / sponsor ID
- SS-0601
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes, Foot, Extremity, Ulcer, Wound, Gauze
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Solsys Medical LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Jul 2008 (estimated)
- First posted
- 19 Oct 2006 (estimated)
- 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.
Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers.
Detailed description
This study will evaluate the use of TheraGauzeT (Soluble Systems, LLC) wound dressing, a polymer hydrogel chemically impregnated into a rayon/polyester formed fabric, forming a pliable, conforming solid matrix. TheraGauze is FDA Class I exempt (regulation #21CFR, product code 5878.4022). It is hypothesized that this material will be useful for the treatment of full-thickness diabetic ulcers. It is further hypothesized that this material will enhance the action of Regranex (becaplermin) gel by providing an optimal environment for this growth factor to function. This study will observe patient outcomes following diabetic foot ulcer treatment with TheraGauze and with or without the use of Regranex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: TheraGauzeTheraGauze alone |
| 2 | Active comparator | Drug: RegranexTheragauze + Regranex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- who are 18 years old or older;
- who are diagnosed as having insulin-dependent or non-insulin-dependent diabetes mellitus (5.5% <HgBA1C<12%);
- who have foot ulcers extending through the epidermis and dermis but not with exposed tendon or bone;
- who have a diagnosis of chronic diabetic ulcer;
- who have a viable wound bed with granulation tissue as determined by bleeding following debridement;
Key exclusion criteria (19 listed)
- having ulcers less than 1cm2 or greater than 16cm2 in size;
- having severe arterial disease (ankle brachial index (ABI) less than 0.65);
- having history of radiation therapy to the ulcer site;
- who use corticosteroids >10mg prednisone daily
- who use any immune suppressive, or severely immunocompromised patients;
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 |
|---|---|---|
| TheraGauzeTheraGauze | Device | 1 |
| RegranexRegranex + TheraGauze | Drug | 2 |
Primary outcome
Frequency of complete wound healing within 12 weeks
Time to complete wound healing within 12 weeks
7 secondary outcomes
Investigator's or clinician's assessment of wound quality (ulcer duration, baseline area, staging, presence of fibrin or granulation tissue)
Patient's assessment (pain, itching)
Presence of epithelialization visible on the wound surface
Occurrence of infection at the wound site
Recurrence of ulcer during the 20 week follow-up period
Adverse events (infection, cellulites, seroma, etc.)
Excess pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Anne Laumann, MBChB, MRCP principal investigator
Northwestern University
Adam Landsman, DPM, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraGauze and Regranex in people with Diabetic Foot Ulcer, run by Solsys Medical LLC 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 8 inclusion and 19 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 7 May 2008. 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?
Results are not available in the source record.
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?
Frequency of complete wound healing within 12 weeks. 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?
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 7 May 2008.