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Foot Ulcer, Diabetic

6
Pipeline Programs
12
Companies
15
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
0
3
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Helixmith
HelixmithKorea - Seoul
1 program
1
EngensisPhase 31 trial
Active Trials
NCT02563522Terminated44Est. Sep 2019
Abbott
AbbottABBOTT PARK, IL
1 program
1
Medical FoodPhase 31 trial
Active Trials
NCT00711217Completed271Est. Dec 2010
Biocorp
BiocorpFrance - Issoire
1 program
1
recombinant human Epidermal Growth FactorPhase 31 trial
Active Trials
NCT02554851Unknown304Est. Dec 2023
Integra LifeSciences
Integra LifeSciencesAustralia - Clayton
5 programs
1
NorLeu3-APhase 21 trial
MatriStemN/A1 trial
PriMatrixN/A1 trial
PriMatrixN/A1 trial
PriMatrix Moist Wound TherapyN/A1 trial
Active Trials
NCT01858545Terminated56Est. Dec 2015
NCT01228500Withdrawn0
NCT01270633Terminated30Est. Sep 2017
+2 more trials
Pfizer
PfizerNEW YORK, NY
2 programs
2
MRE0094Phase 21 trial
MRE0094Phase 21 trial
Active Trials
NCT00312364Completed322Est. Dec 2007
NCT00318214Terminated16Est. Feb 2008
Podimetrics
PodimetricsMA - Somerville
2 programs
Daily use of podimetrics smart-foot matN/A1 trial
Once-daily remote foot temperature monitoringN/A1 trial
Active Trials
NCT02647346Completed132Est. Feb 2015
NCT04345016Completed79Est. Nov 2019
Origin
OriginRUSTON, LA
1 program
APT001N/A1 trial
Active Trials
NCT02356835Completed10Est. Mar 2016
Organogenesis
OrganogenesisCANTON, MA
1 program
NuShieldN/A1 trial
Active Trials
NCT02461641Completed96Est. Oct 2018
Solventum
SolventumMN - St. Paul
1 program
Wound DressingN/A1 trial
Active Trials
NCT01013792Terminated30Est. Jul 2012
Biotest Pharmaceuticals
Biotest PharmaceuticalsGermany - Dreieich
1 program
NorLeu3-APHASE_2

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
HelixmithEngensis
Biocorprecombinant human Epidermal Growth Factor
AbbottMedical Food
Integra LifeSciencesNorLeu3-A
PfizerMRE0094
PfizerMRE0094
PodimetricsOnce-daily remote foot temperature monitoring
OrganogenesisNuShield
OriginAPT001
PodimetricsDaily use of podimetrics smart-foot mat
Integra LifeSciencesMatriStem
Integra LifeSciencesPriMatrix Moist Wound Therapy
Integra LifeSciencesPriMatrix
SolventumWound Dressing
Integra LifeSciencesPriMatrix

Clinical Trials (15)

Total enrollment: 1,560 patients across 15 trials

NCT02563522HelixmithEngensis

Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers

Start: Jun 2017Est. completion: Sep 201944 patients
Phase 3Terminated
NCT02554851Biocorprecombinant human Epidermal Growth Factor

Efficacy and Safety Evaluation of the Intralesional Recombinant Human Epidermal Growth Factor (rhEGF) in Subjects With Diabetic Foot Ulcer.

Start: Jan 2017Est. completion: Dec 2023304 patients
Phase 3Unknown
NCT00711217AbbottMedical Food

Evaluation of a Medical Food for Chronic Wounds

Start: Jun 2008Est. completion: Dec 2010271 patients
Phase 3Completed
NCT00796744Integra LifeSciencesNorLeu3-A

Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers

Start: Oct 2008Est. completion: May 201178 patients
Phase 2Completed
NCT00318214PfizerMRE0094

Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers

Start: Jun 2006Est. completion: Feb 200816 patients
Phase 2Terminated
NCT00312364PfizerMRE0094

Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers

Start: Dec 2005Est. completion: Dec 2007322 patients
Phase 2Completed
NCT04345016PodimetricsOnce-daily remote foot temperature monitoring

Impact of Remote Foot Temperature Monitoring

Start: Apr 2017Est. completion: Nov 201979 patients
N/ACompleted
NCT02461641OrganogenesisNuShield

NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers

Start: Mar 2015Est. completion: Oct 201896 patients
N/ACompleted
NCT02356835OriginAPT001

APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults

Start: Feb 2015Est. completion: Mar 201610 patients
N/ACompleted
NCT02647346PodimetricsDaily use of podimetrics smart-foot mat

In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers

Start: Nov 2013Est. completion: Feb 2015132 patients
N/ACompleted
NCT01858545Integra LifeSciencesMatriStem

A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

Start: May 2013Est. completion: Dec 201556 patients
N/ATerminated
NCT01729286Integra LifeSciencesPriMatrix Moist Wound Therapy

Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix

Start: Sep 2012Est. completion: Oct 201692 patients
N/ATerminated
NCT01270633Integra LifeSciencesPriMatrix

A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Start: Dec 2010Est. completion: Sep 201730 patients
N/ATerminated
NCT01013792SolventumWound Dressing

A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Start: Nov 2009Est. completion: Jul 201230 patients
N/ATerminated
NCT01228500Integra LifeSciencesPriMatrix

The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial

Start: Jan 20080
N/AWithdrawn

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
12 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.