Pressure UlcerNCT01208220
Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers
A study testing Negative Pressure Wound Therapy and Collagenase Ointment in people with Pressure Ulcer and Soft Tissue Necrosis Lower Limb, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a device which by themselves are effective for the treatment of wounds. You are being asked to take part in this study because you have a wound on your body which has not responded to standard treatments. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Soft Tissue Necrosis Lower Limb
- What is being tested?
- Negative Pressure Wound Therapy and Collagenase Ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2011
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 85 year-old competent adults in inpatient setting (no prisoners, mentally ill, or children)
- Pressure ulcers to pelvis/abdomen/trunk and or upper extremities which have been refractory to prior treatment interventions and contain less than or equal to 25% necrotic tissue in wound bed (as percentage of total surface area)
Who cannot join
- Lower extremity/foot wounds related to arterial insufficiency, incarcerated individuals, patients with untreated osteomyelitis, uncorrected coagulopathy, malignancy, sensitivity to collagenase, wounds with evidence of clinical infection (via swab culture or punch biopsy)
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Health Sciences Center
Shreveport, Louisiana, 71103
About this study
Official title: The Effects of Collagenase Santyl Ointment and Negative Pressure Wound Therapy(Npwt) for the Treatment of Chronic Pressure Ulcers.
Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a device which by themselves are effective for the treatment of wounds.
You are being asked to take part in this study because you have a wound on your body which has not responded to standard treatments.
The researchers will be studying whether the combination of two treatments will make wounds heal faster. For those in study, the investigators will treat them with a vacuum device on their wound. Also, some of the people in the study will receive a special ointment and researchers will use special tests to determine if the two treatments together are working better than just one treatment alone.
Read the detailed description
Evaluate the effectiveness of Collagenase Santyl ointment when used in conjunction with NPWT for the treatment of chronic pressure ulcers and determine whether the addition of Collagenase Santyl ointment has a positive effect on wound healing. Through volumetric changes and histological evaluation, we wish to test the hypothesis that the application of Collagenase Santyl ointment in conjunction with NPWT facilitates improved wound healing and mitigates some potentially harmful effects of NPWT alone (e.g. pain with dressing removal and tissue ingrowth
- Conditions
- Pressure Ulcer, Soft Tissue Necrosis Lower Limb
- Being tested
- Negative Pressure Wound Therapy, Collagenase Ointment
- Keywords
- Collagenase Santyl, Enzymatic debridement, maintenance debridement, VAC, NPWT
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Also called NPWT
NPWT changed 3 times weekly
Collagenase OintmentBiological
Apply TIW
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure wound therapy | Active comparator | NPWT changed TIW Receives: Device: Negative Pressure Wound Therapy |
| NPWT plus Collagenase Ointment | Experimental | Collagenase applied TIW with NPWT Receives: Biological: Collagenase Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)
Measured: 2 weeks into study
Secondary outcomes (1)
Removal of Harmful Fluids in the Wound Tissue
Measured: 2 weeks into study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Low enrollment of qualified subjects
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 Pressure 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Collaborators
- Healthpoint
- Responsible party
- Principal investigator, Dr. Stanley McCallon, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Stanley K McCallon, DPT, Principal investigator, LSUHSC professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208220
- Sponsor's protocol ID
- Healthpoint-123-Collagenase
- Status last verified
- Jul 2014
- First submitted
- 16 Apr 2010
- Last updated
- 17 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Collagenase Santyl Ointment and Negative Pressure Wound Therapy(Npwt) for the Treatment of Chronic Pressure Ulcers.
- ClinicalTrials.gov ID
- NCT01208220
- Acronym / sponsor ID
- Healthpoint-123-Collagenase
- Conditions
- Pressure Ulcer, Soft Tissue Necrosis Lower Limb
- Keywords
- Collagenase Santyl, Enzymatic debridement, maintenance debridement, VAC, NPWT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment of qualified subjects
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Collaborators
- Healthpoint
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Posted 17 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a device which by themselves are effective for the treatment of wounds.
You are being asked to take part in this study because you have a wound on your body which has not responded to standard treatments.
The researchers will be studying whether the combination of two treatments will make wounds heal faster. For those in study, the investigators will treat them with a vacuum device on their wound. Also, some of the people in the study will receive a special ointment and researchers will use special tests to determine if the two treatments together are working better than just one treatment alone.
Detailed description
Evaluate the effectiveness of Collagenase Santyl ointment when used in conjunction with NPWT for the treatment of chronic pressure ulcers and determine whether the addition of Collagenase Santyl ointment has a positive effect on wound healing. Through volumetric changes and histological evaluation, we wish to test the hypothesis that the application of Collagenase Santyl ointment in conjunction with NPWT facilitates improved wound healing and mitigates some potentially harmful effects of NPWT alone (e.g. pain with dressing removal and tissue ingrowth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative pressure wound therapy | Active comparator | Device: Negative Pressure Wound TherapyNPWT changed TIW |
| NPWT plus Collagenase Ointment | Experimental | Biological: Collagenase OintmentCollagenase applied TIW with NPWT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 85 year-old competent adults in inpatient setting (no prisoners, mentally ill, or children)
- Pressure ulcers to pelvis/abdomen/trunk and or upper extremities which have been refractory to prior treatment interventions and contain less than or equal to 25% necrotic tissue in wound bed (as percentage of total surface area)
Key exclusion criteria (1 listed)
- Lower extremity/foot wounds related to arterial insufficiency, incarcerated individuals, patients with untreated osteomyelitis, uncorrected coagulopathy, malignancy, sensitivity to collagenase, wounds with evidence of clinical infection (via swab culture or punch biopsy)
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 |
|---|---|---|
| Negative Pressure Wound TherapyAlso: NPWTNPWT changed 3 times weekly | Device | Negative pressure wound therapy |
| Collagenase OintmentApply TIW | Biological | NPWT plus Collagenase Ointment |
Primary outcome
Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)
Time frame: 2 weeks into study
1 secondary outcome
Removal of Harmful Fluids in the Wound Tissue
Time frame: 2 weeks into study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pressure Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
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.
Stanley K McCallon, DPT principal investigator
LSUHSC professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy and Collagenase Ointment in people with Pressure Ulcer and Soft Tissue Necrosis Lower Limb, run by Louisiana State University Health Sciences Center Shreveport 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 Jul 2014. 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 17 Jul 2014). 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?
Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone) (time frame: 2 weeks into study). 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 17 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.