Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327113
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-02-28
Brief Title:
Antibiotic Tumescent For Chronic Wounds
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
A Phase 2 Randomized Study Comparing Subcutaneous Tumescent Antibiotic Administration With Standard of Care for the Treatment of Chronic Wounds
Status:
RECRUITING
Status Verified Date:
2024-03
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:
TAI
Brief Summary:
Chronic non-healing wounds are becoming an increasingly more common problem Eligible consenting patients with chronic leg wounds will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound All patients will continue standard wound care as dictated by the wound care clinic Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits As these specified visits wound size and healing will be documented and patients will complete surveys The study will conclude for the subject after approximately 6 months Again these patients may continue standard wound care but will no longer have study obligations
Detailed Description:
Foot ulcers develop in 91-26 million people with diabetes annually worldwide Up to 1 of people in industrialized countries will suffer from a leg ulcer Numbers of pressure and venous ulcers are rising at rates of 6-7 annually diabetic ulcers rising at 9 In the United States chronic wounds affect 65 million patients and over 25 billion dollars are spent annually on chronic wound care Medicare spending on pressure and arterial ulcers in 2014 was 3696 and 9015 per patient Diabetic limb complications are more costly than breast cancer
Attempts to treat chronic wounds have included 1 debridement 2 specialized dressings 3 compression bandages 4 negative pressure devices 5 topical growth factors and pharmaceuticals 6 skin grafts and skin substitutes 7 hyperbaric oxygen therapy and 8 amputation There is no study that examines the utility of tumescent antibiotic injections TAI into a wound TAI is a relatively simple cost-effective procedure using known drugs with a well characterized safety profile and used in a new way to address this large unmet need
Our group has published work in this area showing appropriate design feasibility and safety in a large animal model The investigators have shown that direct antibiotic delivery through tumescent injections can achieve high antibiotic concentrations directly in skin and soft tissue for sufficient time to kill bacteria Simultaneously total antibiotic doses can be kept low minimizing systemic toxicity In particular even antibiotic resistant strains of pathogenic microorganisms may be susceptible due to the high local concentration of antimicrobial agent Tumescent injections can more effectively deliver antibiotic to compromised body regions with impaired circulation compared to intramuscular or intravenous drug delivery
Primary Objective
1 To assess the safety of tumescent antibiotic injections
Secondary Objectives
1 To evaluate wound size or closure
2 To evaluate chronic-wound-related pain
3 To evaluate Quality of Life
Exploratory Objectives
1 Assess the number of chronic wound-related complications increased wound sizes infections dermatitis
2 Assess the number of clinical signs of infection in participants
3 Determine the species of pathogenic bacteria present in wound
Screening up to 1 week Treatment TAI will take 1 day Standard wound care will be ongoing until the wound closes as it would in a wound care center
Follow-up
Once weekly -1 week for 2 weeks followed by Biweekly -1week for 4 more weeks There will also be a 3 month - 2 weeks and 6 month - 4 weeks follow up visits Total duration of participant participation is up to approximately 1 year Total duration of the study for recruitment and completion of visits is expected to be up to two years
Attempts to treat chronic wounds have included 1 debridement 2 specialized dressings 3 compression bandages 4 negative pressure devices 5 topical growth factors and pharmaceuticals 6 skin grafts and skin substitutes 7 hyperbaric oxygen therapy and 8 amputation There is no study that examines the utility of tumescent antibiotic injections TAI into a wound TAI is a relatively simple cost-effective procedure using known drugs with a well characterized safety profile and used in a new way to address this large unmet need
Our group has published work in this area showing appropriate design feasibility and safety in a large animal model The investigators have shown that direct antibiotic delivery through tumescent injections can achieve high antibiotic concentrations directly in skin and soft tissue for sufficient time to kill bacteria Simultaneously total antibiotic doses can be kept low minimizing systemic toxicity In particular even antibiotic resistant strains of pathogenic microorganisms may be susceptible due to the high local concentration of antimicrobial agent Tumescent injections can more effectively deliver antibiotic to compromised body regions with impaired circulation compared to intramuscular or intravenous drug delivery
Primary Objective
1 To assess the safety of tumescent antibiotic injections
Secondary Objectives
1 To evaluate wound size or closure
2 To evaluate chronic-wound-related pain
3 To evaluate Quality of Life
Exploratory Objectives
1 Assess the number of chronic wound-related complications increased wound sizes infections dermatitis
2 Assess the number of clinical signs of infection in participants
3 Determine the species of pathogenic bacteria present in wound
Screening up to 1 week Treatment TAI will take 1 day Standard wound care will be ongoing until the wound closes as it would in a wound care center
Follow-up
Once weekly -1 week for 2 weeks followed by Biweekly -1week for 4 more weeks There will also be a 3 month - 2 weeks and 6 month - 4 weeks follow up visits Total duration of participant participation is up to approximately 1 year Total duration of the study for recruitment and completion of visits is expected to be up to two years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None