A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
Recruiting · Hollywood, Florida
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Be at least 18 years old.
- •Have type 1 or type 2 diabetes mellitus.
- •Have a diabetic foot ulcer that is the same target ulcer used in the CAMPX study (if there are two or more ulcers, the target must be the same one from CAMPX).
- •Be willing to use the study’s offloading (pressure-relief) method during the study.
- •Agree to weekly study visits and be able to participate in the informed consent process.
🚫 You may not be able to join if…
- •Have a life expectancy of less than 6 months.
- •Have a target ulcer that is not caused by diabetes.
- •Have infection in the target ulcer or surrounding skin (including cellulitis), or signs the ulcer reaches tendon/bone, or osteomyelitis (bone infection).
- •Be receiving medicines that weaken the immune system (including high-dose prednisone/systemic corticosteroids above 10 mg per day or equivalent), cytotoxic chemotherapy, or medications the study doctor thinks could interfere with wound healing (such as biologics).
- •Have HbA1c (a blood sugar average test) greater than or equal to 12% within 3 months of screening, have acute/inactive Charcot foot that interferes with offloading, be pregnant or trying to become pregnant within 6 months, or have end-stage kidney disease requiring dialysis.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–any age
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
Is it safe? Who makes sure of that?+
This is a study of an already-approved treatment (Phase 4). Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT07159282 · Locations: Florida