Diabetic Foot Ulcers (DFU)SCANXNCT07360418
Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.
An observational study of Diabetic Foot Ulcers (DFU) and Foot Ulcer Chronic, run by Applied Biologics, LLC at 1 site in United States.
Trial summary
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers (DFU), Foot Ulcer Chronic, Ulcer
- What is being tested?
- Blue Drop Foot Scanner
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will be drawn from diabetic subjects who have previously completed the CAMPX trial and achieved complete closure.
Who may be able to join
- The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint.
Who cannot join
- The potential subject did not participate in the CAMPX trial.
- The potential subject participated in the CAMPX trial and did not achieve complete closure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Detroit Foot and Ankle
Clinton Township, Michigan, 48038
Lina Barman
About this study
Official title: A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
Read the detailed description
This study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form..
- Being tested
- Blue Drop Foot Scanner
- Keywords
- CAMPX, CAMP, Foot Ulcer, diabetic foot ulcer
- Medical subject headings
- Diabetic Foot, Ulcer, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue Drop Foot ScannerOther
Subjects with eligible wound will receive a BlueDrop® OneStep Foot Scanner™. They are instructed to step on the scale each morning. The Bluetooth technology transmits a photograph and thermal image to the central monitoring nurse at BlueDrop®. All information transmitted is compliant with HIPPA regulations. Subjects that are unable to use the scale will receive a phone call at months 3,6, 9 and 12 months to determine if the foot has remained closed.
| Study group | Role | What they receive |
|---|---|---|
| OneStep Foot Scanner | This study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form. Receives: Other: Blue Drop Foot Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Recurrence
To demonstrate durability of closure (rate of recurrence) of subjects with a closed diabetic foot ulcer during the CAMPX clinical trial comparing subjects treated with Single Layer Amniotic Membrane (SLAM) plus standard of care (SOC) to subjects treated with SOC alone.
Measured: 52 weeks
Secondary outcomes (1)
Virtual Long-Term Follow Up
To evaluate the effectiveness of virtual clinical trial technology in the conduct of a long-term follow up trial.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start16 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcers (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360418
- Sponsor's protocol ID
- Pro00084454
- Acronym
- SCANX
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial
- ClinicalTrials.gov ID
- NCT07360418
- Acronym / sponsor ID
- SCANX / Pro00084454
- Keywords
- CAMPX, CAMP, Foot Ulcer, diabetic foot ulcer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Applied Biologics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
Detailed description
This study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OneStep Foot Scanner | – | Other: Blue Drop Foot ScannerThis study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be drawn from diabetic subjects who have previously completed the CAMPX trial and achieved complete closure.
Key inclusion criteria (1 listed)
- The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint.
Key exclusion criteria (2 listed)
- The potential subject did not participate in the CAMPX trial.
- The potential subject participated in the CAMPX trial and did not achieve complete closure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue Drop Foot ScannerSubjects with eligible wound will receive a BlueDrop® OneStep Foot Scanner™. They are instructed to step on the scale each morning. The Bluetooth technology transmits a photograph and thermal image to the central monitoring nurse at BlueDrop®. All information transmitted is compliant with HIPPA regulations. Subjects that are unable to use the scale will receive a phone call at months 3,6, 9 and 12 months to determine if the foot has remained closed. | Other | OneStep Foot Scanner |
Primary outcome
Rate of Recurrence
Time frame: 52 weeks
To demonstrate durability of closure (rate of recurrence) of subjects with a closed diabetic foot ulcer during the CAMPX clinical trial comparing subjects treated with Single Layer Amniotic Membrane (SLAM) plus standard of care (SOC) to subjects treated with SOC alone.
1 secondary outcome
Virtual Long-Term Follow Up
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcers (DFU) and Foot Ulcer Chronic, run by Applied Biologics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bennett Sarver (1-833-865-6300, info@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Recurrence (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.