ClinicalTrials.Veeva

Menu

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

McMaster University logo

McMaster University

Status and phase

Unknown
Phase 3

Conditions

Foot Ulcer, Diabetic
Venous Ulcer

Treatments

Device: Promagran Dressing
Device: Placebo Dressing
Biological: Becaplermin

Study type

Interventional

Funder types

Other

Identifiers

NCT02845466
Lower Limb Ulcer Topical Ther

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups

Becaplermin/Promagran Dressing
Experimental group
Description:
Topical Becaplermin with a protease inhibitor wound dressing.
Treatment:
Biological: Becaplermin
Device: Promagran Dressing
Becaplermin/Placebo Dressing
Active Comparator group
Description:
Topical Becaplermin with a placebo wound dressing.
Treatment:
Biological: Becaplermin
Device: Placebo Dressing

Trial contacts and locations

1

Loading...

Central trial contact

Steve Phillips, MSc

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems