- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT03854695
Study to Evaluate Bacterial Activity That Drives the Progression of Clinical Infection
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Study Groups:
Participants will be divided 1:1:1 into groups with
- Cohort 1: clinically uninfected (1A and 1C) ulcers.
- Cohort 2: clinically infected (redness, edema, induration, heat, exudate, tenderness/pain (1B and 1D)) with no recent antibiotic therapy (within 28 days)
- Cohort 3: clinically infected (redness, edema, induration, heat, exudate, tenderness/pain (1B and 1D)) on antibiotic therapy
Duration of Subject Participation
- Screening: Within 7 days of baseline visit
- Baseline (can be the same day)
- Week 1 visit: one week after baseline.
- Follow-up period - EMR: 6 months from baseline measurements
- Total duration of subject participation: Up to 6 months
Study Procedures:
Screening
1. Explain purpose and nature of the study and obtain signature on the informed consent document and HIPAA Authorization. 2. Screen the subject against protocol inclusion and exclusion criteria, including all pertinent tests.
Baseline (may be done as same day as screening procedures). This visit may last 1.4-2 hours.
- Obtain general medical history, demographic information and social history.
- Complete a physical examination of the foot, body weight, height, and vital signs, including measurement of resting heart rate, respiratory rate, and blood pressure while seated.
- Select the target ulcer.
- Obtain complete history pertinent to ulcer disease including duration of the target ulcer, previous and current treatment.
- Perform debridement if indicated. Debridement is to be performed using a curette, scissors, scalpel, or forceps.
- Obtain study samples a. 2 blood samples - one for serum and one collected in PAXgene tubes b. 5 tissue samples - one frozen, one fixed in formalin, one placed in RNAlater, one fixed for confocal microscopy and one prepped for SEM analysis.
- Assess the post-debridement ulcer size using a ruler.
- Perform standardized photography of the study wound.
- Perform additional vascular and neuropathy studies.
- Collect all relevant concomitant medications for the previous 28 days.
- Clinician will perform standard wound care, including wound measurements and photography, and apply appropriate dressings/treatment.
- Record wound treatment applied including off-loading and debridement.
- Urine pregnancy test if needed.
Week 1: this visit will not take longer than a normal standard of care visit.
- Assess target ulcer
- Debridement is to be performed using curette, scissors, scalpel, or forceps.
- Obtain study samples a. 2 blood samples - one for serum and one collected in PAXgene tubes b. 5 tissue samples- one frozen, one fixed in formalin, one placed in RNAlater, one fixed for confocal microscopy and one prepped for Scanning Electron Microscopy (SEM) analysis.
- Perform standard of care wound care per physician discretion including wound measurements and standardized photography of the study wound.
- Clinician will perform standard wound care, including wound measurements and photography, and apply appropriate dressings/treatment.
- Record wound treatment applied including off-loading and debridement.
- Any changes in concomitant medications since baseline will be recorded.
- Subject stipend disbursement.
Follow up assessment through medical record
- Wound healing - includes closure or changes in wound size
- Wound treatment - includes details/changes in treatment regimen.
- Labs/Concomitant medications/studies related to wound treatment - includes any studies relative to the medical status, wound status, infection, etc.
- Dehiscence - will be defined as any site along the site of surgical wound closure that fails to have 100% epithelialization without drainage at the time sutures are removed. Often part of the surgical wound will dehisce after it is closed. Therefore, the investigators will evaluate the time until the wound is completely healed. For surgical wounds this will be the time sutures are removed with complete epithelialization of the study wound, or secondary wound healing after previous surgical closure has dehisced.
- Wound infection - infection will be defined and stratified base in the Infectious Disease Society of Americas classification and criteria.
- Amputation - The investigators will document amputation using an ordinal scale (no additional amputation, toe and metatarsal, transmetatarsal amputation, midfoot amputation, below the knee, knee disarticulation, and above the knee amputation).
- Foot related adverse events including hospitalization.
- The investigators will assess perfusion using Arterial dopplers (bedside may be done for screening if formal ABIs have not yet been performed/resulted) as part of the screening procedures. If other procedures are collected as part of standard of care, those data may be acquired from the medical record.
Tanulmány típusa
Kapcsolatok és helyek
Tanulmányi helyek
-
-
Texas
-
Dallas, Texas, Egyesült Államok, 75390
- UT Southwestern Medical Center at Dallas
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
Inclusion Criteria:
Ankle Brachial Index (ABI) ≥ 0.5 (bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery)
- One or more chronic lower extremity wounds that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit, however, only one wound per subject will be included.
- Ulcer grade I or II, Stage A-D, according to University of Texas Wound Classification System
- ≥21 years of age or older
- Diagnosis of diabetes mellitus
Exclusion Criteria:
• Subject has major immunodeficiency
- Subject is human immunodeficiency virus (HIV)+
- Subject has untreated osteomyelitis
- Subject has active cellulitis
- Subject has active charcot
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
- Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years
- Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
---|
Cohort 1
Cohort 1: clinically uninfected (1A and 1C) ulcers.
|
Cohort 2
Cohort 2: clinically infected (redness, edema, induration, heat, exudate, tenderness/pain (1B and 1D)) with no recent antibiotic therapy (within 28 days)
|
Cohort 3
Cohort 3: clinically infected (redness, edema, induration, heat, exudate, tenderness/pain (1B and 1D)) on antibiotic therapy
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Assess serum IgG titers
Időkeret: Five years
|
Assess serum IgG titers against our target antigens and host gene expression analysis
|
Five years
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Characterize microbiology
Időkeret: Five years
|
Characterize microbiology (in particular S. aureus) in diabetic foot ulcers (DFU)
|
Five years
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Characterize immune response
Időkeret: Five years
|
Characterize microbiology and immune response in DFU biopsy material by confocal microscopy and scanning electron microscopy (UTSW)
|
Five years
|
Assess microbiome
Időkeret: Five years
|
Assess microbiome and the host and bacterial transcriptome in DFU
|
Five years
|
Együttműködők és nyomozók
Együttműködők
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Várható)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Patológiás folyamatok
- Szív-és érrendszeri betegségek
- Érrendszeri betegségek
- Bőrbetegségek
- Endokrin rendszer betegségei
- Betegség tulajdonságai
- Diabéteszes angiopátiák
- Lábfekély
- Bőrfekély
- Cukorbetegség szövődményei
- Diabetes mellitus
- Diabéteszes neuropátiák
- Lábbetegségek
- Diabéteszes láb
- Lábfekély
- Fertőzések
- Fertőző betegségek
Egyéb vizsgálati azonosító számok
- 052018-055
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .