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Asset Brief

CYP-006TK

CYP·Cynata Therapeutics·Diabetic foot ulcers (chronic lower-limb wounds associated with diabetes)·Phase 1·NCT05165628·Primary completion: 24 Sept 2024

Plain-language Brief

The trial in plain terms

The disease: Diabetic foot ulcers are open sores or wounds that occur in people with diabetes, typically on the feet. They are a leading cause of hospitalisation and lower-limb amputation in people with diabetes. Standard care includes wound debridement, offloading pressure from the foot, infection control, and moisture-retentive dressings. A meaningful proportion of ulcers do not heal with standard care, driving demand for adjunctive treatments.
What the asset is trying to do: CYP-006TK is a wound dressing that combines Cynata's Cymerus mesenchymal stem cells (MSCs) with a polymer-coated silicone substrate. MSCs are a class of cell derived from bone marrow that are thought to support tissue repair through localised signalling rather than by directly replacing damaged tissue. The Cymerus platform derives MSCs from induced pluripotent stem cells (iPSCs) rather than from individual donors, which is intended to allow more consistent, scalable manufacturing. Applying MSCs directly in a dressing format is intended to deliver the cells to the wound site in a controlled way.
What the trial is measuring, and why it matters: The primary registered trial (NCT05165628) is a Phase 1 study of safety, tolerability, and efficacy of CYP-006TK in adults with diabetic foot ulcers (per ClinicalTrials.gov NCT05165628). Phase 1 trials in wound healing typically assess whether a product causes adverse local or systemic reactions and gather preliminary data on wound closure. The trial targeted 30 participants and had a primary completion date of 24 September 2024 (per ClinicalTrials.gov NCT05165628). The trial status is listed as completed on ClinicalTrials.gov.
Efficacy benchmarks in this setting: In randomised controlled trials of becaplermin gel (PDGF growth factor), the proportion of diabetic foot ulcers achieving complete closure was approximately 50% versus approximately 35% for placebo-treated wounds (per the becaplermin US prescribing information). Wound care biologics and skin substitutes vary widely in reported closure rates depending on wound chronicity, patient selection, and comparator used; direct cross-trial comparisons are not valid. CYP-006TK's Phase 1 trial was not designed or powered for statistical comparison with approved therapies, and any preliminary efficacy figures from that trial are not statistically comparable to the results cited above.

Trial Design

Design summary

Phase: Phase 1
Design type: [ TODO: fill in ] — trial registry lists the study as interventional; full design details not available from provided data.
Primary endpoint: Safety and tolerability of CYP-006TK in adults with diabetic foot ulcers (per ClinicalTrials.gov NCT05165628); efficacy also listed as an objective.
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: 30 patients (per ClinicalTrials.gov NCT05165628)
Current enrolment status: Trial status listed as Completed on ClinicalTrials.gov NCT05165628; primary completion date was 24 September 2024. An ASX announcement dated 26 May 2026 referenced expected timing of clinical trial results, suggesting full results had not yet been publicly reported as of that date.
Sites: [ TODO: fill in ]
Expected readout window: Primary completion occurred 24 September 2024 per ClinicalTrials.gov NCT05165628. An ASX announcement dated 26 May 2026 was titled 'Expected Timing of Clinical Trial Results', indicating results disclosure was pending as of that date. Specific readout date not confirmed in provided data.

Asset Track Record

Did CYP deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

5 July 2026otherBoard, Management Changes, Expenditure Reductions, RDTI Loanhitsrc ASX ↗
17 June 2026data readoutCYP-001 Phase 2 aGvHD top-line resultshit · negativesrc ASX ↗
18 June 2026data readoutCYP-004 Phase 3 osteoarthritis top-line resultshit
18 June 2026data readoutCYP-004 Phase 3 osteoarthritis top-line results (SCUlpTOR)hit · negativesrc ASX ↗
18 June 2026otherReinstatement to Official Quotationhitsrc ASX ↗
15 June 2026otherSuspension from Quotationhitsrc ASX ↗
2 June 2026otherEU Positive Opinion on CYP-001 Paediatric Investigation Planhitsrc ASX ↗
26 May 2026data readoutExpected Timing of Clinical Trial Resultshitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for CYP-006TK and peers

CYP-006TK's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for CYP-006TK. Showing past 6 months and next 12 months · 5 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
BioXTek

Trial design comparison

How CYP-006TK reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
CYP-006TK	Cynata Therapeutics	Mesenchymal Stem Cell	Phase 1[ TODO: fill in ]	[ TODO: fill in ] — trial registry lists the study as interventional; full design details not available from provided data.	Safety and tolerability of CYP-006TK in adults with diabetic foot ulcers (per ClinicalTrials.gov NCT05165628); efficacy also listed as an objective.	[ TODO: fill in ]	30 patients (per ClinicalTrials.gov NCT05165628)	30

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 1 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Mesenchymal Stem CellAllo MSC	Off-the-shelf	Batch (donor)	Ryoncil (GvHD only)	Transient	Low

Mesenchymal Stem CellASX peers ›

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for CYP-006TK yet. Broker coverage of Cynata Therapeutics is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Asset Track Record

Did CYP deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

5 July 2026otherBoard, Management Changes, Expenditure Reductions, RDTI Loanhitsrc ASX ↗
17 June 2026data readoutCYP-001 Phase 2 aGvHD top-line resultshit · negativesrc ASX ↗
18 June 2026data readoutCYP-004 Phase 3 osteoarthritis top-line resultshit
18 June 2026data readoutCYP-004 Phase 3 osteoarthritis top-line results (SCUlpTOR)hit · negativesrc ASX ↗
18 June 2026otherReinstatement to Official Quotationhitsrc ASX ↗
15 June 2026otherSuspension from Quotationhitsrc ASX ↗
2 June 2026otherEU Positive Opinion on CYP-001 Paediatric Investigation Planhitsrc ASX ↗
26 May 2026data readoutExpected Timing of Clinical Trial Resultshitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for CYP-006TK and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
BioXTek

Trial design comparison

How CYP-006TK reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
CYP-006TK	Cynata Therapeutics	Mesenchymal Stem Cell	Phase 1[ TODO: fill in ]	[ TODO: fill in ] — trial registry lists the study as interventional; full design details not available from provided data.	Safety and tolerability of CYP-006TK in adults with diabetic foot ulcers (per ClinicalTrials.gov NCT05165628); efficacy also listed as an objective.	[ TODO: fill in ]	30 patients (per ClinicalTrials.gov NCT05165628)	30

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 1 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Mesenchymal Stem CellAllo MSC	Off-the-shelf	Batch (donor)	Ryoncil (GvHD only)	Transient	Low

Mesenchymal Stem CellASX peers ›

CYP-006TKn = 30

Cynata Therapeutics·Mesenchymal Stem Cell·Phase 1·[ TODO: fill in ]

Design: [ TODO: fill in ] — trial registry lists the study as interventional; full design details not available from provided data.
Primary endpoint: Safety and tolerability of CYP-006TK in adults with diabetic foot ulcers (per ClinicalTrials.gov NCT05165628); efficacy also listed as an objective.
Dosing: [ TODO: fill in ]
Eligibility: 30 patients (per ClinicalTrials.gov NCT05165628)

Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Footn = —

Peking University Third Hospital·Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcersn = —

Cellution Biologics·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcern = —

Peking University Third Hospital·Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Diseasen = —

Biotechnology Institute IMASD·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)n = —

Cellution Biologics·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healingn = —

BioXTek·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.n = —

Royal Biologics·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.n = —

BioLab Holdings·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TLn = —

HealthTech Wound Care·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapyn = —

Sequence LifeScience, Inc.·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcersn = —

BioLab Holdings·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcersn = —

Applied Biologics, LLC·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.n = —

Tiger Biosciences, LLC.·Wound Care Biologic·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcersn = —

Dr Azita Hekmatdoost·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcern = —

Energenesis Biomedical Co., Ltd.·Wound Care Biologic·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)n = —

PolarityTE·Wound Care Biologic·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Phase IIb and III Safety and Efficacy Study Chlorin E6 Gel Photodynamic Therapy for Diabetic Foot Ulcers:n = —

United Medical and Dental College·Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Woundsn = —

Bardia Anvar·Wound Care Biologic·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patientsn = —

Ole Lander Svendsen·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcersn = —

Oneness Biotech Co., Ltd.·Wound Care Biologic·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcersn = —

Zhuhai Rui-Inno Pharmaceutical Technology Co., Ltd.·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Effect of Deferoxamine on Wound Healing Rate in Patients With Diabetes Foot Ulcersn = —

Karolinska University Hospital·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.n = —

Estar Medical dba Medical Technologies, LTD·Wound Care Biologic·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Nu-3 Gel for Infected Diabetic Foot Ulcersn = —

Lakewood-Amedex Inc·Wound Care Biologic·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Assessment of the Efficacy and Tolerance of Sub-cutaneous Re-injection of Autologous Adipose-derived REGEnerative Cells in the Local Treatment of Neuropathic Diabetic Foot ulcERsn = —

Assistance Publique Hopitaux De Marseille·Regenerative Biologic·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot (FOOTCELL)n = —

Medical University of Warsaw·Allogeneic Cell Therapy Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcersn = —

Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.·Peptide Therapeutic·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcersn = —

Blue Blood Biotech Corp.·Wound Care Biologic·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroids) for the Treatment of Refractory Diabetic Foot Ulcers Compared With Standard of Caren = —

FibroBiologics·Regenerative Biologic·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcersn = —

Eluciderm Inc·Wound Care Biologic·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcersn = —

Nicolò Brembilla·Mesenchymal Stem Cell·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureusn = —

Centre Hospitalier Universitaire de Nīmes·Wound Care Biologic·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Stem Cell Derived Exome for Treatment of Diabetic Footn = —

Second Affiliated Hospital of Guangzhou Medical University·Mesenchymal Stem Cell·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Wound Healing Endpoint and Recurrencen = —

Sashwati Roy·Wound Care Biologic·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Class profileexpand ›

Description

Allogeneic mesenchymal stromal/stem cells expanded from donor bone marrow and cryopreserved as an off-the-shelf product. They are not thought to engraft or replace tissue; instead they act transiently through paracrine anti-inflammatory and immunomodulatory signalling before being cleared. That mechanism is distinct from CAR-T or gene therapy and is, in principle, applicable across inflammation-driven indications (graft-versus-host disease, cardiovascular, orthopaedic, autoimmune). Note that one MSC platform can spawn several distinct products: Mesoblast markets remestemcel-L (Ryoncil) for GvHD but uses a separate candidate, rexlemestrocel-L (Revascor), in cardiovascular and back-pain programmes.

Class benchmarks

One MSC product is FDA-approved — remestemcel-L (Ryoncil, Mesoblast), cleared December 2024 for paediatric steroid-refractory acute GvHD after multiple prior complete-response letters. Beyond GvHD the class has a long history of Phase 3 disappointment: large trials in chronic heart failure (Mesoblast DREAM-HF), stroke and ARDS (Athersys MultiStem) and orthopaedic disease have repeatedly missed primary endpoints or produced subgroup-only signals. The recurring pattern is a biologically plausible anti-inflammatory rationale that does not convert into a hard clinical-event benefit at scale.

Commercial track record

Off-the-shelf logistics and a benign safety profile are the commercial attractions; the chronic obstacle is demonstrating a durable, statistically robust effect on hard endpoints. Ryoncil gives the class its first commercial proof point and some manufacturing and reimbursement precedent, but each new indication is effectively a fresh efficacy bet rather than a platform read-through.

Capital intensity

Batch (allogeneic) manufacture from donor marrow scales better on cost-of-goods than autologous cell therapy, but lot-to-lot potency/consistency and cryopreservation logistics are the operational risks. No per-dose economics exist in cardiovascular because no product has reached that market.

Regulatory posture

Contested and slow. Mesoblast received multiple complete-response letters on remestemcel-L (CMC/potency-assay and efficacy-evidence concerns) before the 2024 approval. The FDA has signalled it wants a validated potency assay tying mechanism to clinical effect, and a single positive trial has generally not sufficed for the class. Expect demands for confirmatory hard-endpoint data in any new indication.

Class sources (4)

Ryoncil (remestemcel-L) prescribing information · FDA · accessed 29 May 2026
DREAM-HF chronic heart failure trial (NCT02032004) · ClinicalTrials.gov · accessed 29 May 2026
Mesoblast — investor relations and pipeline · Mesoblast · accessed 29 May 2026
Galipeau J, Sensébé L — Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities (Cell Stem Cell 2018) · Cell Stem Cell · accessed 29 May 2026

NB
Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers
PHASE1/PHASE2
Nicolò Brembilla·Recruiting·Primary completion 1 Dec 2026·NCT07048054
SA
Stem Cell Derived Exome for Treatment of Diabetic Foot
PHASE1/PHASE2
Second Affiliated Hospital of Guangzhou Medical University·Not yet recruiting·Primary completion 30 Dec 2028·NCT06480123

Wound Care BiologicASX peers ›

21 activeexpand ›

CB
Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers
Phase 4
Cellution Biologics·Active, not recruiting·Primary completion 31 Oct 2025·NCT06562296
4 sites
292 enrolled
BI
Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease
Phase 4
Biotechnology Institute IMASD·Recruiting·Primary completion 30 May 2026·NCT06952998
1 site
CB
Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
Phase 4
Cellution Biologics·Recruiting·Primary completion 30 June 2026·NCT07014176
8 sites
PI: Research Director
B
Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
Phase 4
BioXTek·Recruiting·Primary completion 31 July 2026·NCT07326553
2 sites
RB
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
Phase 4
Royal Biologics·Recruiting·Primary completion 14 Aug 2026·NCT07209475
8 sites
BH
A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.
Phase 4
BioLab Holdings·Recruiting·Primary completion 1 Jan 2027·NCT07364630
1 site
HW
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
Phase 4
HealthTech Wound Care·Recruiting·Primary completion 21 Feb 2027·NCT07172893
10 sites
PI: Stan Andrews
SL
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
Phase 4
Sequence LifeScience, Inc.·Recruiting·Primary completion 1 July 2027·NCT07086443
1 site
BH
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Phase 4
BioLab Holdings·Recruiting·Primary completion 1 July 2027·NCT07089602
1 site
AB
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
Phase 4
Applied Biologics, LLC·Recruiting·Primary completion 1 Aug 2027·NCT07159282
1 site
TB
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
Phase 4
Tiger Biosciences, LLC.·Recruiting·Primary completion 1 Dec 2027·NCT06826339
1 site
EB
A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
Phase 3
Energenesis Biomedical Co., Ltd.·Recruiting·Primary completion 30 Dec 2025·NCT05930210
24 sites
P
SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)
Phase 3
PolarityTE·Active, not recruiting·Primary completion 31 Dec 2025·NCT06140303
23 sites
PI: Nikolai Sopko
BA
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Phase 3
Bardia Anvar·Not yet recruiting·Primary completion 1 Jan 2028·NCT07223892
0 sites
OB
Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers
PHASE2/PHASE3
Oneness Biotech Co., Ltd.·Active, not recruiting·Primary completion 8 May 2026·NCT06531512
14 sites
PI: Guang Ning
ED
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
Phase 2
Estar Medical dba Medical Technologies, LTD·Recruiting·Primary completion 15 May 2026·NCT06810726
2 sites
PIs: Adrianne P Smith, Marcus L. Gitterle, Lisa Standlee, FNP, +1
LI
Nu-3 Gel for Infected Diabetic Foot Ulcers
Phase 2
Lakewood-Amedex Inc·Not yet recruiting·Primary completion 1 June 2026·NCT06020235
0 sites
BB
BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers
Phase 2
Blue Blood Biotech Corp.·Recruiting·Primary completion 31 Dec 2027·NCT06383013
5 sites
PI: Shug-Cheng Chang
EI
Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
PHASE1/PHASE2
Eluciderm Inc·Recruiting·Primary completion 1 June 2026·NCT07396376
CH
Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus
PHASE1/PHASE2
Centre Hospitalier Universitaire de Nīmes·Not yet recruiting·Primary completion 1 Nov 2028·NCT02664740
SR
Wound Healing Endpoint and Recurrence
PHASE1/PHASE2
Sashwati Roy·Active, not recruiting·Primary completion 1 Feb 2029·NCT02577120