Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers

NCT00740922

Platelet-Derived Growth Factor Diabetic Foot Neoplasms

COMPLETED

Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers

NCT04267640

Peripheral Artery Disease Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease Chronic Limb Threatening Ischemia +1 more

UNKNOWN PHASE2

PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4

NCT02652169

Chronic Skin Ulcer

RECRUITING NA

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

NCT06952998

Foot Ulcers, Diabetic

RECRUITING PHASE4

A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers

NCT00069446

Foot Ulcer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Ulcer Foot Ulcer, Diabetic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Becaplermin/Promagran Dressing

Topical Becaplermin with a protease inhibitor wound dressing.

Group Type EXPERIMENTAL

Becaplermin

Intervention Type BIOLOGICAL

0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks.

Promagran Dressing

Intervention Type DEVICE

44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks.

Becaplermin/Placebo Dressing

Topical Becaplermin with a placebo wound dressing.

Group Type ACTIVE_COMPARATOR

Becaplermin

Intervention Type BIOLOGICAL

0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks.

Placebo Dressing

Intervention Type DEVICE

Inactive wound dressing.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Becaplermin

0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks.

Intervention Type BIOLOGICAL

Promagran Dressing

44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks.

Intervention Type DEVICE

Placebo Dressing

Inactive wound dressing.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Regranex Aquacel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and women aged ≥18 years
* Ulcer size 1-64 cm²
* Ulcer extends through both the epidermis and dermis, with no exposed tendon or bone
* Ulcer duration \>3 months
* Ulcer located between and including the knee and ankle
* For venous leg ulcers - Venous refilling time \<25s on photoplethysmography or abnormal venous insufficiency Duplex scan
* For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a haemoglobin A1C \< 12%
* Wounds have not been treated with Promogran in the previous 4 weeks
* Patients able to give informed consent

Exclusion Criteria

* Ankle-brachial index \<0.8
* Ulcer with local or systemic signs of infection
* Patients who have been previously treated with Becaplermin gel
* Receiving corticosteroids or immune suppressants
* History of autoimmune disease
* Uncontrolled diabetes (baseline haemoglobin A1C \> 12%)
* Severe rheumatoid arthritis
* Uncontrolled congestive heart failure
* Malnutrition (albumin \<2.5g/dL)
* Unable to adhere to the protocol
* Known sensitivities to the wound dressings used in the trial
* A history of any previous malignancy
* pregnant or lactating women

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No