Interim results from the CAMPAIGN randomized controlled trial reported a 98.5% posterior probability that lyophilized human amnion/chorion membrane (EPIEFFECT) is superior to standard of care in nonhealing diabetic foot ulcers. The study’s predefined success criterion was a posterior probability of 90% or higher. The analysis was based on 71 enrolled patients; a subsequent presentation using an expanded 88-patient dataset suggested further separation between groups. Enrollment remains ongoing.
The core development is a formal RCT signal now published in the International Journal of Tissue Repair and showcased at the Tissue Research Evidence Summit. CAMPAIGN is designed to compare EPIEFFECT against standard wound care using a Bayesian framework that allows probability-based assessments during enrollment. The company also referenced predictive modeling, pointing to superiority at completion, positioning the interim as more than an underpowered snapshot and rather as a structured checkpoint consistent with adaptive design norms in this category.
Strategically, this is an evidence acceleration move aimed squarely at payer policy inflection points, not a regulatory pivot. With new Local Coverage Determinations scheduled to take effect January 1, 2026, for cellular and tissue-based products used in chronic wounds, suppliers face a higher bar for randomized, well-controlled data that aligns with contemporary criteria around patient selection, offloading, outcome assessment, and statistical rigor. Mimed has largely leaned on real-world evidence for EPIEFFECT since its 2023 launch; this interim RCT signal marks a necessary shift to meet evolving MAC expectations and preserve or expand coverage in a crowded category facing utilization controls and formulary scrutiny. The Bayesian design also indicates a time- and capital-conscious approach that can generate a persuasive probability of benefit without waiting for full enrollment, useful in payer negotiations ahead of LCD implementation.
Operationally, wound centers and research sites should anticipate increasing demand for rigorously controlled chronic wound trials that operationalize offloading, run-in periods, standardized photography, and blinded endpoint adjudication. CAMPAIGN’s framework, if mirrored broadly, will raise execution complexity at community sites but also create predictable workflows for CRO partners and imaging vendors. For sponsors across the wound care segment, this readout validates the use of Bayesian interim analyses and predictive probabilities to align trial timelines with reimbursement milestones. Payers will be looking for more than probability statements: effect sizes on complete closure within prespecified windows, time to closure, durability and recurrence rates, infection and amputation events, and resource utilization will determine whether superiority translates into meaningful clinical and economic benefit under the new LCDs.
The next phase hinges on the final dataset: completeness of healing outcomes, durability at follow-up, safety signals, and whether the study triggers any early-stopping criteria. Watch for whether MACs adopt product-agnostic thresholds that still require robust RCTs or move toward naming products that meet criteria, as this will affect coding and utilization management. Sites will need clarity on visit cadence, application frequency, and documentation standards to operationalize coverage if inclusion is secured. Competitors with amniotic- or fibroblast-based matrices are likely to accelerate their own RCTs or publish pooled analyses to avoid exclusion in 2026. One unresolved variable is the regulatory environment for human tissue products, which can shift unexpectedly and alter evidentiary expectations. If the final CAMPAIGN readout sustains or improves on this interim probability with clinically meaningful effect sizes, the study could influence both payer policy and procurement decisions across outpatient wound centers heading into the LCD changeover.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
