Supporting Blinded Wound Endpoint Capture with Clinion EDC Across 22 Trial Sites
Overview
Diabetic foot ulcer studies depend on consistent wound assessment over time. In this Phase III stem cell therapy study, the sponsor needed to track whether target ulcers achieved complete closure, whether that closure was sustained, and how ulcer size changed across a 24-week follow-up period.
The study evaluated peri-ulcer administration of the investigational product in patients with non-healing diabetic foot ulcers. It was designed as a randomized, double-blind, placebo-controlled, multicenter study across 22 centers in India, with efficacy focused on wound healing and safety assessed through adverse events, laboratory data, ECG parameters, vital signs, and physical examination findings.
Clinion EDC was used as the central data capture platform across the study’s 22 participating sites. It helped the study team track patient eligibility across screening, randomization, and pre-administration checks, capture long-term wound healing outcomes, and maintain a consistent blinded data environment across the national site network.
Study Snapshot
Industry
Biotech
Client
Regenerative medicine sponsor
Study Type
Interventional
Therapeutic Area
Diabetic Foot Ulcer / Regenerative Medicine
Study Phase
Phase III
Study Design
Randomized, double-blind, placebo-controlled, multicentre, single-dose study
Randomization
Double-blind
Region
India
Site Count
22 sites
Submission
DCGI / public registry record
Study Duration
25 months as per registry record and project input
Products Provided
Challenges
Tracking Eligibility, Wound Healing, and Blinded Data Across 22 Sites
This cell therapy trial required more than routine visit data capture. Each patient record had to carry eligibility decisions, wound healing progress, and blinded study data from screening through the final follow-up visit.
01
Managing Eligibility Across Multiple Checkpoints
Eligibility had to be confirmed at screening, again before randomization, and once more before investigational product administration. The challenge was keeping each decision connected to the same patient record, so sites could move patients through the trial without losing the link between screening, randomization, and treatment readiness.
02
Capturing Wound Healing Outcomes Over 24 Weeks
The study needed to track complete ulcer closure, sustained closure, and reduction in ulcer size across a long follow-up period. The challenge was keeping wound status and measurement data consistent across visits, so each patient’s healing progress could be reviewed clearly over time.
03
Maintaining Blinded Data Consistency Across 22 Sites
The trial was designed to keep participants, investigators, and outcome assessors blinded. Across 22 sites, the sponsor needed the same data capture structure at every location, so study records remained consistent without creating risks to the blinded review process.
Solutions
A Structured Clinion EDC Workflow for Multi-Stage Eligibility and Long-Term Data
Clinion EDC was configured to support this trial’s three-stage eligibility process, its long-term wound healing endpoints, and its blinded, nationwide site network.
Outcomes
Core Results
Clinion EDC helped the sponsor keep a complex 22-site DFU trial organized around each patient’s progression through eligibility, treatment, and follow-up.
Patient Journey Continuity
Screening, randomization, pre-administration, and follow-up data stayed connected within the same EDC record.
Assessment-Ready Visit Data
Each visit captured the required wound and safety data in a format ready for review.
Nationwide Data Control
The sponsor gained one consistent view of data activity across all 22 participating sites.
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Compliance
Fully Compliant with Global Standards
