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Virus Therapy
Phage Therapy for Diabetic Foot Osteomyelitis (DANCE Trial)
Phase 2
Recruiting
Led By Edward Fang
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
Must not have
Healing of the ulcer by more than 30% between screening and randomization
Taking and/or receiving any therapies for the study ulcer that are not considered to be SOC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 13
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.
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.
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.
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.
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I am between 18 and 84 years old.
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I have been diagnosed with diabetes.
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I am between 18 and 84 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My ulcer has healed by more than 30% before starting the trial.
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I am not using any non-standard treatments for my ulcer.
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I have had liver disease in the past 3 months.
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I haven't taken antiviral medication in the last 2 weeks.
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My liver tests are not normal.
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My body weight is less than 50 kg.
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I have an ulcer on my leg, mostly above the inner ankle bone.
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I might have a tumor related to my ulcer, regardless of biopsy results.
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I have a skin infection that is not limited to just one ulcer.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent area reduction of study ulcer through Week 13
Secondary study objectives
Complete healing of the study ulcer
Microbiological eradication of the target pathogen
Time to 85% reduction of C-reactive protein (CRP)
Other study objectives
Treatment-emergent AEs due to phage therapy
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
917 Previous Clinical Trials
334,573 Total Patients Enrolled
Adaptive Phage Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
1 Total Patients Enrolled
Edward FangPrincipal InvestigatorChief Medical Officer
Robert HopkinsPrincipal InvestigatorChief Medical Officer
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.
Osteomyelitis Patient Testimony for trial: Trial Name: NCT05177107 — Phase 2