Table 2.

Weekly assessment for all study participants

Ulcer assessment and measurement

- Consistency of wound edges, fibrin, peri-wound erythema, peri-wound edema, peri-wound induration, qualitative quality of foot/leg edema, granulation tissue, necrotic tissue (amount), exudate (type), exudate (amount), wound size (cm2), pain and presence of epithelialization

Lab tests per protocol

Sharp debridement

Wound cleansing and moist wound healing dressing

Digital photograph using the Silhouette Aranz camera

- Device that provides three-dimensional measurement and documentation of the wound surface area, depth and volume, along with storage and wound informatics management, i.e., graphic depiction of wound progression timeline

Infection/ osteomyelitis assessment if indicated with confirmatory bacterial culture

- Deep swab curette, tissue specimen/biopsy), radiographs and blood work (CBC, ESR, CRP, and chemistry). Note: if radiograph suggests but does not confirm osteomyelitis, then follow-up studies of bone scan, bone biopsy, or MRI or CT imaging will be obtained as deemed necessary by investigator clinician

Use of an offloading device that protects the wound from pressure or trauma related to ambulation and other acts of daily living

- The total contact cast or instant total contact cast would be ideal offloading devices. However, given the nature and complexities associated with DFU, it is unrealistic to expect that all patients will tolerate such offloading devices. Thus, the offloading device provided will be dependent on the subject’s ability to tolerate the specific offloading device. Adherence to offloading device will be evaluated by the investigator at each visit by observing plantar wear patterns and inquiring from the patient if offloading was used consistently as instructed. Alternative to total contact cast or instant total contact cast (camwalker), offloading devices will be offered including, but not limited to, the use of felt/foam adhesive/post op shoe, custom offloading insole, and customized healing shoe in combination with gait assistive devices such as a roll-a-bout scooter, walker, wheelchair, or motorized scooter.

Smoking cessation counseling

Note: Blood glucose monitoring/management will be addressed by the consultant endocrinologist for any patient with HbA1C above 8

Group A: SOC plus Timoptic-XE®. The subjects will receive the SOC treatment as described above plus Timoptic-XE®

Group B: SOC plus non-biologically active gel (hydrogel, as placebo medication)

All other procedures are as in the SOC group