How to Select Sites for Diabetic Foot Ulcer (DFU) Studies in Wound Care Medical Device Investigations
Why Site Selection Matters in DFU Clinical Trials
Running a clinical trial in diabetic foot ulcers (DFU) is challenging: patients are heterogeneous, healing potential depends on perfusion, and dropout rates are high. Choosing the right sites determines whether your study delivers robust data or stalls.
Recruitment Strategy: Community + Hospital Split
Community sources:
podiatry clinics, wound centers, GP networks, home nurses.
Hospital sources:
tertiary DFU centers, vascular units (only stable Wagner 3).
Pre-screen workflow:
referral intake → ulcer age/size/perfusion check → offloading acceptance → consent.
Expect screen:randomize ratios ~3:1, and plan for ≤15% dropout.
Standardize Care to Reduce Noise
Sponsors must enforce a Standard of Care (SOC) package across sites:
- Sharp debridement protocol.
- Offloading (TCC preferred, removable boots tracked).
- Infection management pathway.
- Glycemic management rules.
This minimizes variability and supports regulatory acceptance.
Data Quality & Retention
Imaging dry-run:
≥90% pass before first patient in.
Retention bundle:
transport support, home-nurse visits, tele-checks.
QC KPIs:
imaging reject rate <10%, protocol deviations <10%, SAE reporting on time.
Conclusion
Site selection is the most critical success factor in DFU medical device trials. Sponsors should prioritize vascular capability, offloading adherence, imaging QC, and patient retention logistics. A structured feasibility checklist ensures predictable timelines and reliable outcomes.
Why ECLEVAR MEDTECH is the Partner of Choice for DFU Studies
While many CROs claim expertise in wound care, ECLEVAR MEDTECH brings a unique advantage:
Pre-assessed site network:
We maintain a network of DFU and VLU centers already evaluated for patient flow, vascular diagnostics, and research readiness.
Systematic feasibility assessment:
Every site undergoes a structured, data-driven feasibility review before being activated.
Streamlined contracting:
Master Clinical Trial Agreements (MCTA) are already in place with multiple hospitals and wound care centers, accelerating start-up by weeks to months.
Trusted relationships:
Our established collaborations with key opinion leaders (KOLs) in Europe ensure motivated investigators and high-quality data.
👉 With ECLEVAR, sponsors avoid the common pitfall of "underperforming sites" and gain immediate access to centers with proven recruitment capability.
Client Testimonial
"Partnering with ECLEVAR MEDTECH saved us months in site activation and gave us access to centers that were already trained and contracted. Their systematic feasibility process and close relationships with investigators made our DFU study execution seamless."
REGENLAB - EUROPEAN DFU STUDY
Why ECLEVAR MEDTECH Makes Feasibility Faster and Smarter
Conducting feasibility in wound care is complex , but ECLEVAR MEDTECH simplifies the process:
Ready-to-go sites:
ECLEVAR has already conducted systematic assessments of many wound care centers, ensuring reliability of patient volume, perfusion diagnostics, and infrastructure.
Centralized network:
Sponsors benefit from immediate access to our European network of DFU/VLU investigators, reducing the time from feasibility to first-patient-in.
Master Agreements:
Pre-negotiated contracts with key hospitals remove one of the biggest barriers to rapid trial initiation.
MILO Site Select & Contract:
Our proprietary digital platform, MILO, integrates feasibility surveys, site assessment scoring, and automated contracting workflows. This means faster site evaluation, streamlined legal negotiation, and real-time visibility on readiness status.
👉 By leveraging our network + MILO technology, sponsors avoid redundant feasibility rounds and achieve faster, smoother study start-up.
Best Practices for Site Feasibility Surveys in DFU Wound Care Studies
- Use structured questionnaires: capture patient volume, Wagner distribution, vascular diagnostics, offloading resources, staffing.
- Assess recruitment channels: community nurses vs tertiary hospitals.
- Demand objective perfusion testing: toe pressure is the gatekeeper.
- Pilot imaging QC: require sites to submit test photos before activation.
- Plan for Go/No-Go gates: e.g., ≥2 randomized patients/month, retention ≥85%.
Well-designed feasibility surveys de-risk DFU studies and avoid costly underperforming sites.
Ready to Launch Your DFU Study?
Partner with ECLEVAR MEDTECH for pre-assessed sites, systematic feasibility, and faster study start-up.
Book a Consultation