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Leg UlcersPhase 1NCT00007280

Bioengineered Skin and Wound Healing

A Phase 1 study testing Bioengineered skin in people with Leg Ulcers, run by Roger Williams Medical Center at 1 site in United States.

Completed

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

Official record
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Trial summary

This study will look at whether a graft of bioengineered skin (BSC), known commercially as Apligraf, stimulates the healing process in a person's own skin at the edge of a wound (known as the edge effect). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leg Ulcers
What is being tested?
Bioengineered skin
Type of treatment
Medical device
How many people
50 participants
Where
1 siteUnited States
Study dates
Oct 2000to Aug 2005
Phase
Phase 1
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

  • Men or women at least 18 years old
  • At least one ulcer (wound) greater than or equal to 2 centimeters
  • Ulcer (wound) present for at least 3 months or greater
  • Ankle/brachial index > 0.7
  • Patient must be ambulatory
  • Patient must read, understand and sign informed consent

Who cannot join

  • Medical conditions limiting participation
  • History of poor compliance, unreliability
  • History of allergy to bovine collagen
  • Gangrene, vasculitis, collagen vascular disease osteomyelitis or exposed tendons
  • Use of systemic steroids/immunosuppressives
  • History of diabetes mellitus

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roger Williams Medical Center Dept. of Dermatology & Skin Surgery

    Providence, Rhode Island, 02908

Other trials in United States

About this study

Official title: Mechanisms of Bioengineered Skin in Human Wounds

This study will look at whether a graft of bioengineered skin (BSC), known commercially as Apligraf, stimulates the healing process in a person's own skin at the edge of a wound (known as the edge effect). The information from this study will provide a better understanding of the ways that grafts of bioengineered skin help the healing of chronic wounds.

We will assign study participants to either the bioengineered skin group or the control group. People in the control group will receive compression therapy with a multilayered compression bandage. We will examine each participant before starting treatment and then once a week for 24 weeks or until the wound heals. On the first day of treatment (day 0) and at week 3, week 6, and week 24 (end of treatment) we will take a small tissue sample from the wound for a biopsy. After the wound is completely healed, we will ask the patient to return once a month for 6 months to make sure the wound stays healed.

Read the detailed description

BSC is a two-layered sheet made from purified beef tendon collagen, living human cells, and a substance that maintains the cells until they are grafted (removed). We will obtain human cells from donors unrelated to the patient. The human cells have been tested for the presence of infectious agents and found to be free of disease-causing organisms such as hepatitis virus, the AIDS virus, bacteria, and fungi.

We will randomly assign (randomize) study participants to either the bioengineered skin group or control group (compression therapy with a multilayered compression bandage). Regardless of the group to which a patient is assigned, we expect participation in this study for 12 months following the start of study treatment. We will examine each patient at the screening visit (2 weeks before randomization) and then again 3-4 days before the start of treatment to make sure the wound is free of any signs of infection. After the initial randomization visit we will examine the wound once a week for 24 weeks or until the wound heals, whichever is earlier. As soon as we have determined that the wound is completely healed, we will ask the patient to return once a month for 6 months to make sure it remains healed.

Bioengineered skin group: We will apply BSC to the wound and cover it with xeroform dressing, foam bolster, gauze dressing, and compression bandage. If we do not note any improvement at the week 6 visit, we will apply BSC on the wound a second time.

Control group: We will place a multilayered compression bandage on the wound of participants assigned to this group.

Biopsies (small piece of skin tissue): At day 0 a biopsy will be taken from the thigh and leg ulcer. The biopsy from the thigh will require sutures and will be removed in ten days. Sometime between weeks 1 and 3, week 6, week 24 and week 48 (6 month follow-up) visits a biopsy will be taken from the ulcer (wound) if the ulcer has not healed. If the ulcer is healed at the week 48 visit, a light scraping of the healed wound will be performed.

Study examinations: All study examinations will include observation, measurement, and photography.

We can only admit women of childbearing age to the study if they are not breast feeding, not pregnant, or have been surgically sterilized or are using effective birth control. Because the effects of the proposed treatments on a fetus are unknown, we will remove from the study any woman who becomes pregnant while receiving BSC applications (day 0-week 3) and suggest another method of treatment.

Conditions
Leg Ulcers
Being tested
Bioengineered skin
Keywords
Bioengineered skin, Venous leg ulcer
Medical subject headings
Leg Ulcer, Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioengineered skinDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement and characterization of stimulation of the wound's edges treated with the bioengineered skin construct (BSC)

    Measured: Measured throughout the study till Week 48

Secondary outcomes (2)

  1. Response of BSC to injury, including meshed (wounded) and unmeshed BSC

    Measured: Measured throughout the study till Week 48

  2. Activation of certain critical cytokines, including IL-1 alpha, IL-6, and TGF-beta

    Measured: Measured throughout the study till Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2000 (estimated)
  2. Study startOct 2000
  3. Primary completionAug 2005
  4. Study completionAug 2005

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00007280
Sponsor's protocol ID
R01AR046557
Other IDs
R01AR046557, NIAMS-060
Status last verified
Apr 2008
First submitted
16 Dec 2000
Last updated
2 Aug 2013
Results posted
No

Publications

  • Falanga V, Sabolinski M. A bilayered living skin construct (APLIGRAF) accelerates complete closure of hard-to-heal venous ulcers. Wound Repair Regen. 1999 Jul-Aug;7(4):201-7. doi: 10.1046/j.1524-475x.1999.00201.x.

    PubMed 10781211

  • Falanga V, Isaacs C, Paquette D, Downing G, Kouttab N, Butmarc J, Badiavas E, Hardin-Young J. Wounding of bioengineered skin: cellular and molecular aspects after injury. J Invest Dermatol. 2002 Sep;119(3):653-60. doi: 10.1046/j.1523-1747.2002.01865.x.

    PubMed 12230509

  • Nahm WK, Zhou L, Falanga V. Sustained ability for fibroblast outgrowth from stored neonatal foreskin: a model for studying mechanisms of fibroblast outgrowth. J Dermatol Sci. 2002 Feb;28(2):152-8. doi: 10.1016/s0923-1811(01)00157-8.

    PubMed 11858954

  • Phillips TJ, Manzoor J, Rojas A, Isaacs C, Carson P, Sabolinski M, Young J, Falanga V. The longevity of a bilayered skin substitute after application to venous ulcers. Arch Dermatol. 2002 Aug;138(8):1079-81. doi: 10.1001/archderm.138.8.1079.

    PubMed 12164746

  • Badiavas EV, Falanga V. Treatment of chronic wounds with bone marrow-derived cells. Arch Dermatol. 2003 Apr;139(4):510-6. doi: 10.1001/archderm.139.4.510.

    PubMed 12707099

  • Kim BC, Kim HT, Park SH, Cha JS, Yufit T, Kim SJ, Falanga V. Fibroblasts from chronic wounds show altered TGF-beta-signaling and decreased TGF-beta Type II receptor expression. J Cell Physiol. 2003 Jun;195(3):331-6. doi: 10.1002/jcp.10301.

    PubMed 12704642

  • Shen JT, Falanga V. Growth factors, signal transduction, and cellular responses. J Dermatol. 2003 Jan;30(1):5-16.

    PubMed 12598704

  • Nahm WK, Philpot BD, Adams MM, Badiavas EV, Zhou LH, Butmarc J, Bear MF, Falanga V. Significance of N-methyl-D-aspartate (NMDA) receptor-mediated signaling in human keratinocytes. J Cell Physiol. 2004 Aug;200(2):309-17. doi: 10.1002/jcp.20010.

    PubMed 15174101

  • Brem H, Kirsner RS, Falanga V. Protocol for the successful treatment of venous ulcers. Am J Surg. 2004 Jul;188(1A Suppl):1-8. doi: 10.1016/S0002-9610(03)00284-8.

    PubMed 15223495

  • Saap LJ, Donohue K, Falanga V. Clinical classification of bioengineered skin use and its correlation with healing of diabetic and venous ulcers. Dermatol Surg. 2004 Aug;30(8):1095-100. doi: 10.1111/j.1524-4725.2004.30334.x.

    PubMed 15274699

  • Butmarc J, Yufit T, Carson P, Falanga V. Human beta-defensin-2 expression is increased in chronic wounds. Wound Repair Regen. 2004 Jul-Aug;12(4):439-43. doi: 10.1111/j.1067-1927.2004.12405.x.

    PubMed 15260809

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bioengineered skin in people with Leg Ulcers, run by Roger Williams Medical Center 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 6 inclusion and 6 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 2 Aug 2013. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Measurement and characterization of stimulation of the wound's edges treated with the bioengineered skin construct (BSC) (time frame: Measured throughout the study till Week 48). 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 NCT00007280, which also lists 11 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 2 Aug 2013.

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