A Pilot Safety and Efficacy Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers

 

Eligibility

Inclusion Criteria:

  • Patient with documented stable Type I or II diabetes (HbA1C confirmation every 4 months)
  • Patient’s ulcer is present for a minimum of 2 weeks under Investigator’s care
  • Study ulcer has healed <50% in size during 2 weeks leading up to enrollment
  • Study ulcer is on plantar surface of the foot
  • Ulcer ≥1 cm2 at Day 0 of study*
  • Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule
  • Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting 2 weeks after initial presentation
  • Patient has adequate circulation to the foot as evidenced by palpable pulse
  • Ankle-Brachial Index (ABI) and Toe-Brachial Index (TBI) of ≥0.7? (mild to moderate obstruction)
  • Female patients are not pregnant at time of, or during study
  • Patient and caregiver ready and willing to participate and comply with follow-up regime
  • Patient or legal representative has read and signed the Institutional Ethics Review Board approved informed consent form

* – ulcer usually presents as around 1 cm2 but is greater after debridement 

Exclusion Criteria:

  • Evidence of gangrene on affected foot
  • Ulcer is over Charcot deformity (fractures or dislocation)
  • Ulcer is non-diabetic in etiology
  • Ulcer has tunnels or sinus tracts that cannot be completely debrided
  • Patient’s HgAIC < 12
  • Medical condition(s) that in the Investigator’s opinion make the patient inappropriate for study
  • Patient has/had malignant disease not in remission for 5 years or more
  • Patient has acute or chronic Hepatitis, Cirrhosis, has serum albumin <2.0 gms/dL, or has alkaline phosphatase or LDH at twice the normal upper limit
  • Patient receiving oral or parenteral corticosteroids, immunosuppression or cyctotoxic agents, or is anticipated to require such agents during study
  • Patient received radiation therapy within 30 days of Day 0 of study
  • Patient has AIDS or is infected with HIV
  • Patient has participated in another study using investigational drug(s) or device within the previous 30 days
  • Obvious clinical signs and symptoms of cellulitis and osteomyelitis
  • Patient has any other conditions which seriously compromises their ability to complete the study
  • Patient has known allergies to antibiotics such as Penicillin and Streptomycin
  • Patient has history of bleeding disorder
  • Patient received elective osseous procedures to study foot with 30 days prior to screening visit
 

Contact

PI
Dr Mark Glazebrook

Description

A Pilot Safety and Efficacy Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers

Sample size= 8