Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005569
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-04-22
Brief Title:
Effects of Topical SLPI on Skin Wounds
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Topical Anti-Inflammatory Agents on Cutaneous Wound Healing
Status:
COMPLETED
Status Verified Date:
2003-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effects of a protein called secretory leukocyte protease inhibitor SLPI on skin wound healing Produced naturally by the body SLPI modifies levels of elastase a substance that breaks down the skin Older people are at greater risk of impaired wound healing with increased elastase activity and inflammation In addition men heal more slowly than women Delayed healing is associated with infection and pain and can lead to the development of chronic non-healing skin wounds
Healthy men and women between 60 and 80 years old who wish to participate in this study will have a brief history and physical evaluation to determine their eligibility Those enrolled will be randomly assigned to receive a gel form of SLPI applied topically on the skin surface to a skin wound or a placebo a look-alike gel with no active ingredient Participants will undergo the following procedures
First visit - The skin will be numbed with a local anesthetic and two small 4 mm wounds about the size of a pencil eraser made in each upper arm The drug or placebo will be applied to the wound and gauze placed over it Two blood samples 20 ml and 7 ml will be drawn an hour apart to determine blood levels of SLPI
Second visit - The day after the first visit the wound dressing will be removed and the participant will be evaluated for pain at the wound site allergic reactions or infection A blood sample 7 ml will be taken
Third visit - The wounds will be examined and photographed to evaluate healing In addition the strength of the wound may be assessed by means of a vacuum system placed on the skin This may cause a tingling sensation over the wound A piece of all four wounds will be removed after the skin has been numbed and a dressing applied
Fourth visit - The wounds will be examined for healing and the dressing removed
Healthy men and women between 60 and 80 years old who wish to participate in this study will have a brief history and physical evaluation to determine their eligibility Those enrolled will be randomly assigned to receive a gel form of SLPI applied topically on the skin surface to a skin wound or a placebo a look-alike gel with no active ingredient Participants will undergo the following procedures
First visit - The skin will be numbed with a local anesthetic and two small 4 mm wounds about the size of a pencil eraser made in each upper arm The drug or placebo will be applied to the wound and gauze placed over it Two blood samples 20 ml and 7 ml will be drawn an hour apart to determine blood levels of SLPI
Second visit - The day after the first visit the wound dressing will be removed and the participant will be evaluated for pain at the wound site allergic reactions or infection A blood sample 7 ml will be taken
Third visit - The wounds will be examined and photographed to evaluate healing In addition the strength of the wound may be assessed by means of a vacuum system placed on the skin This may cause a tingling sensation over the wound A piece of all four wounds will be removed after the skin has been numbed and a dressing applied
Fourth visit - The wounds will be examined for healing and the dressing removed
Detailed Description:
The proposed clinical trial will evaluate the efficacy and safety of topically-applied Secretory Leukocyte Protease Inhibitor SLPI peptide as a treatment for impaired wound healing states in 60-80 year old subjects who are at greatest risk of delayed wound healing Administration of the drug topically should result in reduced elastase activity and inflammation leading to accelerated matrix deposition and wound healing Subjects will be randomly allocated to one of four possible groups topical administration of SLPI or placebo wounds excised at day 7 post-wounding or topical administration of SLPI or placebo wounds excised at day 50 post-wounding The dose of SLPI will be determined in a dose-finding pilot study prior to the main study Initial 4mm punch biopsies will be made in both upper inner arms two per arm followed by topical administration of SLPI or placebo The wounds will be left to heal and all four wounds excised at either day 7 for 50 of the volunteers or day 50 post-wounding for the other 50 of volunteers The incidence of side-effects and the rate of healing will be determined at these time-points Successful demonstration of an enhanced therapeutic effect may provide a basis for the development of strategies to accelerate wound healing in those situations where it is comprised such as with age and in chronic non-healing wounds
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-D-0116 | None | None | None |