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Virus Therapy
Phage Therapy for Diabetic Foot Osteomyelitis (DANCE Trial)
Phase 2
Recruiting
Led By Edward Fang, MD
Research Sponsored by Adaptive Phage Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have undergone or are scheduled to undergo surgical debridement for DFO as part of SoC, with the associated bone culture positive for S. aureus
Male or female ≥18 to <85 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 13
Awards & highlights
DANCE Trial Summary
This trial is testing whether a virus that kills bacteria can help treat diabetic foot osteomyelitis.
Who is the study for?
This trial is for adults aged 18-85 with diabetic foot osteomyelitis (DFO), who are receiving standard care including antibiotics and have had or will have debridement. Participants must have a bone culture positive for S. aureus, matchable by available phages, good past treatment compliance, ongoing diabetes diagnosis, and adequate limb circulation without anticipated revascularization.Check my eligibility
What is being tested?
The study is testing bacteriophage therapy versus placebo in patients with DFO. It's a phase IIa randomized trial where participants receive either the phage therapy or a placebo alongside their standard treatments to see if it improves outcomes.See study design
What are the potential side effects?
While specific side effects of bacteriophage therapy aren't listed here, common concerns may include allergic reactions to the phages or potential interactions with existing medications or conditions.
DANCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery to remove infected tissue, and tests show I have an infection caused by S. aureus.
Select...
I am between 18 and 84 years old.
Select...
I have been diagnosed with diabetes.
Select...
I am between 18 and 84 years old.
DANCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 13
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent area reduction of study ulcer through Week 13
Secondary outcome measures
Complete healing of the study ulcer
Microbiological eradication of the target pathogen
Time to 85% reduction of C-reactive protein (CRP)
Other outcome measures
Treatment-emergent AEs due to phage therapy
DANCE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1: Phage TherapyExperimental Treatment1 Intervention
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Group II: Group 2: PlaceboPlacebo Group1 Intervention
Placebo (normal saline) will be administered using the same schedule and techniques as for Group 1 (phage therapy).
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
865 Previous Clinical Trials
327,573 Total Patients Enrolled
Adaptive Phage Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
1 Total Patients Enrolled
Edward Fang, MDPrincipal InvestigatorChief Medical Officer
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ulcer has healed by more than 30% before starting the trial.I am getting standard care, including antibiotics, for my bone infection.There is at least one type of bacteria-killing virus that can treat the specific infection found in a bone culture.I am not using any non-standard treatments for my ulcer.I am having surgery to remove infected tissue, and tests show I have an infection caused by S. aureus.I have followed my doctor's advice in the past and am willing to follow treatment plans for my ulcer.I am between 18 and 84 years old.I have been diagnosed with diabetes.My blood flow in the affected limb is good and I don't need surgery to improve it.You are allergic to phage products.You have tested positive for HIV-1 and/or HIV-2.I have had liver disease in the past 3 months.I haven't taken antiviral medication in the last 2 weeks.I am between 18 and 84 years old.I have not had hyperbaric oxygen or cell/tissue treatments in the last 30 days.My liver tests are not normal.My body weight is less than 50 kg.I have an ulcer on my leg, mostly above the inner ankle bone.I am able to understand and follow the study's requirements.I might have a tumor related to my ulcer, regardless of biopsy results.Your hemoglobin level is less than 7 grams per deciliter.I have a skin infection that is not limited to just one ulcer.You have a medical device implanted where the study drug needs to be administered.I haven't taken antibiotics in the last 2 weeks, except for diabetic foot issues.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Placebo
- Group 2: Group 1: Phage Therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Foot Osteomyelitis Patient Testimony for trial: Trial Name: NCT05177107 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants aged under 40 eligible for this medical experiment?
"The investigators are looking for clinical trial participants who have surpassed the age of majority, but not yet reached 85 years old."
Answered by AI
What objectives is this research attempting to achieve?
"This experiment aims to measure the percentage of area reduction for study ulcers by Week 13. Secondary outcomes include a timeline for complete healing, percentage of patients with healed ulcers within 7 weeks and microbial eradication rates at each collection point in time."
Answered by AI
In what localities has this research been implemented?
"The trial is being run in 10 different locations, such as Jersey Shore University Medical Center in Neptune, Southern Arizona VA Health Care System in Tucson and James J. Peters VA in Bronx, among other sites."
Answered by AI
Are researchers actively seeking participants for this trial?
"As per clinicaltrials.gov, this medical trial is in the process of patient recruitment. This research was initially listed on November 24th 2021 and has been recently revised during September 12th 2022."
Answered by AI
Has the FDA sanctioned Phage Therapy?
"Although there is some evidence confirming its safety, Phage Therapy received a score of 2 as clinical trials have yet to demonstrate efficacy."
Answered by AI
What criteria must prospective participants fulfill to qualify for this trial?
"This clinical trial seeks 126 people, ages 18-85 with a diagnosis of osteomyelitis that identify as male or female."
Answered by AI
How many participants are eligible for the research project?
"The study requires a total of 126 participants who satisfy the protocol's criteria. Adaptive Phage Therapeutics, Inc., is spearheading this investigation with trial sites located at Jersey Shore University Medical Center in Neptune, New jersey and Southern Arizona VA Health Care System in Tucson, Arizona."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New Jersey
How old are they?
18 - 65
What site did they apply to?
Futuro Clinical Trials, LLC
Jersey Shore University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I’ve been having this affliction for more than two years and didn’t know what it was until I was diagnosed pre diabetic and then I did some research and went to my primary care physician and confirmed it. Looking for and upcoming research for a bothersome affliction.
PatientReceived 1 prior treatment
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