- First diabetic foot ulcer (DFU) study in the US
utilizing a modified platform trial design to demonstrate the
efficacy of multiple products in a single clinical trial.
- First to incorporate continuous glucose monitoring in a
cellular, acellular, matrix-like product (CAMP) DFU
study
ROSWELL,
Ga., June 4, 2024 /PRNewswire/ -- StimLabs, a
leading regenerative medicine company, announced Institutional
Review Board (IRB) authorization to begin the CAMPSTIM clinical
trial, a multi-center randomized controlled trial to demonstrate
the real-world benefits of StimLabs' placental-based tissue
products in treating patients with hard-to-heal diabetic foot
ulcers (DFUs).
"This trial is the first US master trial design in non-healing
DFU studies to demonstrate the efficacy of multiple products in a
single trial, the first DFU trial to utilize continuous glucose
monitoring, and the largest prospective DFU trial involving
placental-based CAMPs," said Thomas E.
Serena, MD, FACS, FACHM, MAPWCA, Founder and Medical
Director of SerenaGroup®, and Principal Investigator for the trial.
He added, "This platform, and similar master trial designs,
represent the future of clinical research in the industry.
SerenaGroup is excited to manage this innovative study with the
StimLabs team, who have consistently demonstrated innovation in
wound care."
In the United States, DFUs
occur in 1.6M patients with diabetes
annually1. These ulcers commonly recur and often lead to
severe complications such as skin and soft tissue infections,
osteomyelitis, amputation, sepsis, and death. The longer a DFU
remains open, the greater the risk of complication.2
Despite advances in treatment, less than 50% of DFUs are healed at
12 weeks.3 Additionally, greater than 90% of DFUs with
less than a 50% area reduction at 4 weeks of standard of care (SOC)
do not go on to heal.4 These alarmingly poor healing
rates highlight the need for effective CAMPs, also known as skin
substitutes, in patients suffering from DFUs.
"In collaboration with SerenaGroup, we have carefully designed a
comprehensive and standardized trial utilizing advanced
technologies to ensure the highest quality results," said
John Daniel, Founder and CEO of
StimLabs. The CAMPSTIM trial features a protocol that will drive
consistency across sites through the inclusion of digital devices
to provide wound measurements and bacterial load and the
incorporation of continuous glucose monitoring for every patient.
Furthermore, it standardizes the use of Mölnlycke Health Care's
market-leading dressing, Mepilex® Border Flex as well as the
additional use of Mölnlycke's gelling fibre dressing, Exufiber® in
highly exudating wounds.
CAMPSTIM will evaluate at least four separate StimLabs CAMPs
(Enverse®, Revita®, Relese® and Cogenex®) with SOC compared to SOC
alone, in treating patients with non-healing DFUs. The study
utilizes a unique modified platform trial design, adapted from
clinical trials developed during the pandemic to test multiple
interventions within a single trial. It is the first such
design used for DFUs in the US. As the largest planned prospective
clinical study to date on placental tissue allografts, CAMPSTIM
will enroll approximately 272 patients across multiple sites in the
US.
The primary endpoint of the study will be the percentage of
target ulcers achieving complete wound closure in 12 weeks.
Secondary endpoints include time to closure, percentage of wound
area reduction, number of adverse events, and changes in pain and
quality of life.
"This highly vulnerable patient population will benefit greatly
from the best technologies to support their wound care. Through
this novel trial, we look forward to showcasing the power of our
unique placental tissue allograft portfolio," said John Daniel.
Unlike many placental allografts on the market, the StimLabs
product configurations used in this study retain all three layers
of the native placental membrane: the amnion, chorion, and
intermediate layer. This is made possible using the patented
Clearify® technology, which preserves the integrity of the membrane
by ensuring it remains intact during processing. By never
delaminating the tissue, StimLabs grafts result in complete,
full-thickness products which retain the essential structural
proteins and growth factors that play a crucial role in wound
resolution.
About StimLabs
StimLabs LLC's mission is to advance
the state of regenerative medicine, with a current focus in wound
care and surgical applications. Comprised of industry leaders,
StimLabs is dedicated to offering patients the best possible care
while recognizing the urgency of providing solutions in areas with
unmet needs. StimLabs has a comprehensive product portfolio
addressing various clinical applications and has established a
strong intellectual property catalog. Committed to delivering
superior products, StimLabs is a trusted partner to physicians and
patients alike. https://stimlabs.com.
About Mölnlycke
Mölnlycke Health Care is a world-leading MedTech company that
specialises in innovative solutions for wound care and surgical
procedures. Mölnlycke products and solutions are used daily by
hospitals, health care providers and patients in over 100 countries
around the world. Founded in 1849, Mölnlycke is owned by Investor
AB and headquartered in Sweden.
www.molnlycke.com
Media Contact:
StimLabs
378634@email4pr.com
(470) 616-0958
1. Voelker R. What Are Diabetic Foot
Ulcers? JAMA. 2023;330(23):2314.
doi:10.1001/jama.2023.17291
2. National Diabetes Foot Care Audit:
https://digital.nhs.uk/data-and-information/clinical-audits-and-registries/national-diabetes-foot-care-audit.
Accessed 3February2024.
3. Fife CE, Eckert KA, Carter MJ. Publicly Reported Wound
Healing Rates: The Fantasy and the Reality. Adv Wound Care (New
Rochelle). 2018 Mar 1;7(3):77-94.
doi: 10.1089/wound.2017.0743. PMID: 29644145; PMCID:
PMC5833884.
4. A Post-hoc Analysis of Reduction in Diabetic Foot Ulcer
Size at 4 Weeks as a Predictor of Healing by 12 Weeks. (2010).
Wound Management & Prevention, 56(3).
https://www.hmpgloballearningnetwork.com/site/wmp/content/a-post-hoc-analysis-reduction-diabetic-foot-ulcer-size-4-weeks-a-predictor-healing-12-weeks
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