Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s)

Inclusion Criteria:

1. Male or female ≥18 years of age

2. Either 2 wounds on 1 leg or 1 wound on each leg or only 1 wound. Wound(s) must be
located below the knee.

3. At least one wound must have a surface area ≥5 cm2 and ≤50 cm2 and it also must be
present for ≥4 weeks

4. Mean global score ≥1.18 on the Wound-QoL questionnaire (this will be calculated by the
electronic data capture [EDC] system at the time of screening to assess eligibility)

5. Willingness to wear an off-loading device if medically indicated (e.g., DH shoe or
walker)

Exclusion Criteria:

1. Prior treatment with Prontosan solution or Prontosan gel on the wound(s)

2. Infection in the wound(s)

3. Cartilage exposure in the wound(s)

4. Antibiotic therapy within 7 days prior to baseline (i.e., prior to first
administration of study treatment). Topical antibiotics not applied to the wound are
acceptable.

5. Current diagnosis of severe peripheral artery disease as indicated by clinical
findings (i.e., no palpable pulse on both dorsal pedis and posterior tibial arteries
of the affected limb) or an Ankle Brachial Index of < 0.5

6. Presence of gangrene in the wound(s) or on the leg(s)

7. Active (flare up) rheumatic or collagen vascular disease (including rheumatoid
arthritis, scleroderma, and systemic lupus erythematosus), psoriasis, sarcoidosis, or
other skin disease. These subjects are allowed to receive oral, inhaled, or parenteral
corticosteroids, immunosuppressive agents, or cytotoxic agents. Note: fibromyalgia is
acceptable.

8. Osteomyelitis diagnosed by x-ray, bone biopsy, or other radiological procedure within
90 days prior to the screening visit

9. Active radiation therapy below the hip

10. Subjects with medical conditions other then those identified in Exclusion Criteria 7
who are currently receiving or has received oral, or parenteral corticosteroids,
immunosuppressive agents, or cytotoxic agents within 30 days prior to baseline (i.e.,
prior to first administration of study treatment) or is anticipated to require such
agents during the course of the study

11. Clinical laboratory values that may impair wound healing; for example, hemoglobin <10
g/dL, or HbA1c ≥12%

12. Enrolled in any investigational drug or device study for any disease/indication within
30 days prior to the screening visit

13. Unable to comprehend or comply with study requirements, or inability to sign an
informed consent form

14. Allergic to any of the components in Prontosan solution or Prontosan gel

15. Patients who, in the opinion of the Investigator, would not be suitable candidates for
this study or have some impediment to their ability to heal

16. Preplanned surgery or procedures that would occur during the study (other than deemed
minor and clinically non-significant by the Investigator) or that would interfere with
the study

17. Phase 4 pressure ulcer as defined by full-thickness skin and tissue loss with exposed
or directly palpable fascia, muscle, tendon, ligament, cartilage or bone in the ulcer.
Slough and/or eschar may be visible

18. Severe secondary lymphedema as diagnosed by clinical findings in inferior members
(e.g., legs)

19. A diagnosis of malnutrition as determined by either a low BMI (<18.5 kg/m2), or on the
combined finding of weight loss together with reduced BMI (age-specific)

20. Employee of the Investigator or study center, with direct involvement in the study or
other studies under the direction of that Investigator or study center, as well as
family members of the employees or the Investigator