Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT01924806
Eligibility Criteria:
Inclusion Criteria
Subjects who meet the following criteria may be included in the clinical investigation, if they present with ALL of the following:
1. Subject is able to understand the evaluation and willing to consent and comply with all post-debridement visits and procedures
2. Age 18 years and older. Subjects may be of either sex and of any race or skin type
3. Subjects fulfilling any one or all of the following criteria:
1. chronic wound(s) below the level of the knee, defined by delayed healing or cellular senescence
2. acute wound(s) as a result of a surgical procedure, laceration, abrasion or trauma
3. diabetic foot ulcer(s)
4. subjects with venous leg ulcers below the knee on the leg or foot with one or more documented failure of maximal medical therapy for their study wound \>30 days such as compression bandages (low elasticity, elastic, multilayered, elastic and non elastic compression)
4. Subjects with the following lab results within 30 days of treatment:
1. serum albumin level \>20g/L
2. clinically non significant results of liver function test (LFTs), serum glucose and complete blood count (CBC) with differential
5. Subjects with a Braden Score ≥13-14 (Moderate Risk)
6. Subjects with adequate arterial blood flow \[Ankle-Brachial Index (ABI) \>0.75\]
Exclusion Criteria
Subjects will be excluded from the clinical investigation, if they present with ANY of the following:
1. Subjects that have tunneling wounds
2. Subject presents with an active infection in the study wound, as defined by purulence and:
1. Fever and leukocytosis
OR any TWO of the following:
2. Malodor, pain or tenderness, warmth, erythema, induration, swelling, lymphangitis
3. Infected bone diagnosed by imaging modality (e.g., Magnetic Resonance Imaging (MRI) and/or radiographic images)
4. Subjects whose study wound does not require debridement
5. Cardiac pacemaker or other electronic implant(s)
6. Subjects with irradiate, burn or ischaemic wounds or history of keloids
7. Subjects with vasculitis, non-reconstructive peripheral vascular disease, pyoderma gangrenosum, renal failure or lymphoedema
8. Subjects with uncontrolled bleeding disorder (PT/PTT) and coagulopathy (including those with hemophilia)
9. Subjects taking treatment with any of the following:
1. Systemic corticosteroids
2. Immunosuppressive agent(s)
3. Chemotherapy or Radiation therapy
10. Subjects deemed to require biologic dressing/ skin substitute
11. Terminally ill subjects
12. Subjects that have an immunodeficiency disorder that interferes with wound healing, including Acquired Immunodeficiency Syndrome (AIDS) or know to be infected with Human Immunodeficiency Virus (HIV)
13. Subjects that have chronic skin conditions such as psoriasis, etc.
14. Subjects that reside in a nursing home
15. Subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant
16. Subject is pregnant and/or intending to become pregnant during this clinical investigation period
17. Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to enrollment for clinical investigation entry
18. Subject is excluded if they have received an investigational therapy or approved therapy for investigational use within 30 days of surgery
19. Subject is excluded if planning to participate in another research study during the follow-up phase of this study or 84 days after study completion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01924806
Study Brief:
Protocol Section:
NCT01924806