Venous UlcerXCellNCT00446823
Effectiveness of XCell on Autolytic Debridement of Venous Ulcers
A study testing XCell cellulose wound dressing and Impregnated gauze dressing in people with Venous Ulcer, run by Xylos Corporation at 3 sites in United States.
Trial summary
This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- XCell cellulose wound dressing and Impregnated gauze dressing
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2002to Dec 2003
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of any race and are between 18 and 90 years of age.
- Patients that are able to understand and are willing to give written informed consent.
- Patients that have a non-healing open venous ulcer for at least one month.
- Patients that have greater than 50% of the ulcers surface area covered with non-viable tissue such as fibrin slough, dry crust or a combination of both.
- Patients that have the clinical signs and symptoms of venous ulceration such as varicosities, hyper pigmentation, stasis dermatitis, lipodermatosclerosis, and edema.
- Patients that have a venous ulcer with a surface area of greater than or equal to 1.5 cm2.
- Patients that have an ankle to brachial index (ABI) > 0.70.
Who cannot join
- Study wound (target ulcer) etiology is other than venous insufficiency.
- Patient has peripheral arterial disease as determined by the following criteria: Ankle/Brachial Index < 0.7 (ulcerated leg), evidence of intermittent claudication.
- Patient has the presence of any of the following in the area of the ulcer: cellulitis, osteomyelitis, and ulcer with exposed bone, tendon or fascia.
- Patient has a known hypersensitivity to dressing components.
- Patient is receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy where in the investigator's opinion could interfere with wound healing .
- Patient is known to have uncontrolled diabetes mellitus (as defined by the investigator).
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- Patient is known to have immunodeficiency disorders that interfere with wound healing.
- Patient has a history of sickle cell anemia, thalassemia, vasculitis, rheumatoid arthritis, lupus erythematosus, polyarteritis nodosa, scleroderma or any connective tissue or collagen vascular disorder.
- Patient has wounds that have been treated with an investigational product within the past thirty days.
- Patient has not signed the informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston University School of Medicine
Boston, Massachusetts, 02118
Etris Associates
Philadelphia, Pennsylvania, 19116
University Wound Care Center
The Bronx, New York, 10461
About this study
Official title: A Prospective, Randomized, Controlled Clinical Study to Evaluate the Effectiveness of a Cellulose Matrix Wound Dressing for Autolytic Debridement and Healing of Chronic Venous Ulcers
This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed. Results will compare venous ulcers treated with Xylos XCell cellulose dressing plus standard care to those treated with standard care alone. The hypothesis is that XCell will demonstrate more autolytic debridement than the standard of care.
Read the detailed description
Chronic wounds are a problem for both the patient and the health care provider. The definition of a chronic wound is one that deviates from the expected sequence of repair in time, appearance and response to aggressive treatment. These wounds can be separated into distinct classes by etiology, specifically, pressure, ischemic, venous, neuropathic, diabetic, inflammatory or infective wounds. The degree of severity can be quite diverse spanning the range of superficial epidermal injury to full-thickness skin loss with extensive destruction, tissue necrosis, and damage to supporting structures including muscle, tendon, and or bone. Treatment of chronic wounds should begin with the management of the underlying etiology. For example: In pressure ulcers the elimination or reduction of pressure is the primary goal; In venous ulcers, improving venous insufficiency or reducing venous hypertension should come first; and in diabetic foot ulceration, proper off loading is essential. After treatment of the underlying pathology, one thing that all chronic wounds have in common is that they require wound bed preparation in order to stimulate the healing process.
Most clinical wound care trials to evaluate therapeutic agents for wounds have been designed to measure healing as the primary endpoint. The sequence of events begins with patient examination, wound classification and then the application of the test agent. In most cases, the test agent is placed over a wound that is contaminated with excessive bacteria, needs debridement, or requires wound bed preparation such as exudate control.
A new wound dressing (Xylos XCell cellulose wound dressing) is a unique biosynthetic matrix material that is hydrophilic and has excellent tensile strength. It has the ability to deliver moisture into a wound or absorb moisture. This cellulose matrix is microbially derived, biocompatible, pyrogen-free and completely non-toxic. In previous clinical trials this dressing displayed the ability to aid the natural process of autolytic wound debridement, cleansing and exudate control. From initial observations, it appears that this cellulose matrix provides an environment that prepares the wound bed by eliminating nonviable tissue, reducing bacterial burden, controlling exudate and exposing healthy granulation tissue. With successful wound bed preparation one can now concentrate on healing the chronic wound.
This clinical trial is designed to evaluate the natural cleansing (autolytic debridement process) and healing attributes of this new cellulose wound dressing compared to standard of care (impregnated gauze). Venous ulcers have been chosen as the model because these wounds are often covered with thick fibrous non-viable tissue, are poorly vascularized, are contaminated with numerous bacteria and exude copious amount of wound fluid.
- Conditions
- Venous Ulcer
- Being tested
- XCell cellulose wound dressing, Impregnated gauze dressing
- Keywords
- Wound healing, Venous stasis ulcer, Cellulose dressing, Gauze dressing, Chronic wound
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCell cellulose wound dressingDevice
Impregnated gauze dressingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of dressing to autolytically debride wound
Secondary outcomes (2)
To evaluate and compare healing of wounds treated with XCell or control
To evaluate level of pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startJun 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous 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
- 50 participants
Sponsor and investigators
- Lead sponsor
- Xylos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Oscar M Alvarez, Ph.D., Principal investigator, University Wound Clinics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446823
- Sponsor's protocol ID
- XC-0201-VU
- Acronym
- XCell
- Status last verified
- Mar 2007
- First submitted
- 9 Mar 2007
- Last updated
- 13 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Frankel VH, Serafica GC, Damien CJ. Development and testing of a novel biosynthesized XCell for treating chronic wounds. Surg Technol Int. 2004;12:27-33.
PubMed 15455308Alvarez OM, Patel M, Booker J, Markowitz L. Effectiveness of a biocellulose wound dressing for the treatment of chronic venous leg ulcers: Results of a single center randomized study involving 24 patients. WOUNDS 16(7):224-233, 2004
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Clinical Study to Evaluate the Effectiveness of a Cellulose Matrix Wound Dressing for Autolytic Debridement and Healing of Chronic Venous Ulcers
- ClinicalTrials.gov ID
- NCT00446823
- Acronym / sponsor ID
- XCell / XC-0201-VU
- Conditions
- Venous Ulcer
- Keywords
- Wound healing, Venous stasis ulcer, Cellulose dressing, Gauze dressing, Chronic wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Xylos CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Dec 2003
- First posted
- 13 Mar 2007 (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.
This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed. Results will compare venous ulcers treated with Xylos XCell cellulose dressing plus standard care to those treated with standard care alone. The hypothesis is that XCell will demonstrate more autolytic debridement than the standard of care.
Detailed description
Chronic wounds are a problem for both the patient and the health care provider. The definition of a chronic wound is one that deviates from the expected sequence of repair in time, appearance and response to aggressive treatment. These wounds can be separated into distinct classes by etiology, specifically, pressure, ischemic, venous, neuropathic, diabetic, inflammatory or infective wounds. The degree of severity can be quite diverse spanning the range of superficial epidermal injury to full-thickness skin loss with extensive destruction, tissue necrosis, and damage to supporting structures including muscle, tendon, and or bone. Treatment of chronic wounds should begin with the management of the underlying etiology. For example: In pressure ulcers the elimination or reduction of pressure is the primary goal; In venous ulcers, improving venous insufficiency or reducing venous hypertension should come first; and in diabetic foot ulceration, proper off loading is essential. After treatment of the underlying pathology, one thing that all chronic wounds have in common is that they require wound bed preparation in order to stimulate the healing process.
Most clinical wound care trials to evaluate therapeutic agents for wounds have been designed to measure healing as the primary endpoint. The sequence of events begins with patient examination, wound classification and then the application of the test agent. In most cases, the test agent is placed over a wound that is contaminated with excessive bacteria, needs debridement, or requires wound bed preparation such as exudate control.
A new wound dressing (Xylos XCell cellulose wound dressing) is a unique biosynthetic matrix material that is hydrophilic and has excellent tensile strength. It has the ability to deliver moisture into a wound or absorb moisture. This cellulose matrix is microbially derived, biocompatible, pyrogen-free and completely non-toxic. In previous clinical trials this dressing displayed the ability to aid the natural process of autolytic wound debridement, cleansing and exudate control. From initial observations, it appears that this cellulose matrix provides an environment that prepares the wound bed by eliminating nonviable tissue, reducing bacterial burden, controlling exudate and exposing healthy granulation tissue. With successful wound bed preparation one can now concentrate on healing the chronic wound.
This clinical trial is designed to evaluate the natural cleansing (autolytic debridement process) and healing attributes of this new cellulose wound dressing compared to standard of care (impregnated gauze). Venous ulcers have been chosen as the model because these wounds are often covered with thick fibrous non-viable tissue, are poorly vascularized, are contaminated with numerous bacteria and exude copious amount of wound fluid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of any race and are between 18 and 90 years of age.
- Patients that are able to understand and are willing to give written informed consent.
- Patients that have a non-healing open venous ulcer for at least one month.
- Patients that have greater than 50% of the ulcers surface area covered with non-viable tissue such as fibrin slough, dry crust or a combination of both.
- Patients that have the clinical signs and symptoms of venous ulceration such as varicosities, hyper pigmentation, stasis dermatitis, lipodermatosclerosis, and edema.
Key exclusion criteria (10 listed)
- Study wound (target ulcer) etiology is other than venous insufficiency.
- Patient has peripheral arterial disease as determined by the following criteria: Ankle/Brachial Index < 0.7 (ulcerated leg), evidence of intermittent claudication.
- Patient has the presence of any of the following in the area of the ulcer: cellulitis, osteomyelitis, and ulcer with exposed bone, tendon or fascia.
- Patient has a known hypersensitivity to dressing components.
- Patient is receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy where in the investigator's opinion could interfere with wound healing .
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 |
|---|---|---|
| XCell cellulose wound dressing | Device | – |
| Impregnated gauze dressing | Device | – |
Primary outcome
Ability of dressing to autolytically debride wound
2 secondary outcomes
To evaluate and compare healing of wounds treated with XCell or control
To evaluate level of pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2007.
- Results publication: PubMed 15455308Frankel VH, Serafica GC, Damien CJ. Development and testing of a novel biosynthesized XCell for treating chronic wounds. Surg Technol Int. 2004;12:27-33.
- Results publicationAlvarez OM, Patel M, Booker J, Markowitz L. Effectiveness of a biocellulose wound dressing for the treatment of chronic venous leg ulcers: Results of a single center randomized study involving 24 patients. WOUNDS 16(7):224-233, 2004
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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.
Oscar M Alvarez, Ph.D. principal investigator
University Wound Clinics, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XCell cellulose wound dressing and Impregnated gauze dressing in people with Venous Ulcer, run by Xylos Corporation at 3 sites 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 7 inclusion and 10 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 13 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ability of dressing to autolytically debride wound. 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 NCT00446823, which also lists 2 linked publications.
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 13 Mar 2007.