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NCT06310239 · ClinicalTrials.gov registry record
Microbiome Population Adaptation Study
A clinical trial of Amputation With Osseointegration, sponsored by Walter Reed National Military Medical Center.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT06310239 is a study of Amputation With Osseointegration that is actively recruiting participants, run by Walter Reed National Military Medical Center. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06310239, a study of Amputation With Osseointegration, is actively recruiting participants, sponsored by Walter Reed National Military Medical Center.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will accomplish our research aims by collecting cutaneous microbiome samples from 50 persons that have undergone the Osseointegration (OI) surgery at eight timepoints, prospectively. The investigators will also collect control samples to correct for turnovers in species compositions that may naturally occur and to compare the residual limb microbiome to the sound contralateral limb. The investigators will sequence the bacterial community using universal bacterial primers. Using these sequences, The investigators will borrow from ecological theory and calculate the alpha and beta diversity. The alpha diversity will determine the species and abundance of each species that are present, while the beata diversity will allow us to compare how species assemblages and frequencies change between time points. Then, the investigators will take a phylogenetic modeling approach to determine if particular species assemblages correlate with rates of wound healing. The investigators will construct phylogenies from the sequences at the different time points and "paint" the rate of wound healing along the phylogeny (e.g., improved, stagnated, worsened). Using Akaike and Bayesian information criterion, the investigators can determine which phylogenetic model best explains the patterns the investigators see across patients. Lastly, the investigators will quantify soft tissue stability and health and correlate this with the homeostasis of the microbial community. Specifically, the investigators will determine if redundant soft tissue leads to altered microbial communities that can impact the rate of wound healing. Finally, the investigators will further stratify these data to compare microbial communities between the sexes, upper versus lower limbs, and proximal versus distal amputations. This work will allow us to better treat infections after OI surgery and can shed light on wound healing process so that the investigators can better treat limb loss patients and the m
Conditions Studied
Interventions
- OTHER Collection of biologic samples and data
Study Locations (1)
Maryland
- Orhopaedic Surgery Service, Walter Reed National Military Medical Center, - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2029-11-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06310239
The ClinicalTrials.gov registry entry for NCT06310239 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amputation With Osseointegration appearing as the primary indexed condition, and to 1 intervention - of which Collection of biologic samples and data is the first listed.
NCT06310239 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06310239 about?
NCT06310239 is a clinical study titled "Microbiome Population Adaptation Study". The investigators will accomplish our research aims by collecting cutaneous microbiome samples from 50 persons that have undergone the Osseointegration (OI) surgery at eight timepoints, prospectively. The investigators will also collect control samples to correct for turnovers in species composition...
What is the current status of trial NCT06310239?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2023-12-01. Estimated completion is 2029-11-30.
What conditions does trial NCT06310239 study?
This clinical trial studies the following conditions: Amputation With Osseointegration.
What interventions are being tested in trial NCT06310239?
The interventions under investigation include: Collection of biologic samples and data (OTHER).
Who is sponsoring clinical trial NCT06310239?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06310239 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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