Efficacy of a New Heparan Sulfate Mimetic Dressing in the Healing of Foot and Lower Extremity Ulcerations in Type 2 Diabetes

Abstract

A novel heparan sulfate glycosaminoglycan mimetic product for local application to promote wound healing (CACIPLIQ) has recently become available. It is a biophysical therapeutic product comprising a polysaccharide as an innovative biomaterial to accomplish mechanical tissue engineering and skin regeneration in the site of ulceration. We present a series of 12 patients with type 2 diabetes (4 men and 8 women; age 53-87 years; diabetes duration 8-25 years) having chronic resistance to therapy for foot and lower extremity ulcerations. CACIPLIQ was locally applied twice per week after careful debridement. Complete ulcer healing was accomplished in all patients after a mean treatment duration of 4.92 months (range = 2-12 months). The product was very well tolerated. In conclusion, these results, although preliminary, are encouraging and suggest adequate efficacy and safety of the new product in difficult-to-heal foot and lower extremity ulcerations in type 2 diabetes.

RGTA® or ReGeneraTing Agents mimic heparan sulfate in regenerative medicine: from concept to curing patients

“…Most cases concern chronic ulcers, associated with severe limb ischemia [55] (Roohi, in preparation), diabetes [56–58], burns [57, 59] pressure [57] and vascular defects [57], as well as in individual patients presenting with ulcers caused by sickle cell disease [60] radiation [61] and epidermolysis bullosa [62] (Table 2). In addition to chronic wounds, RGTA ® has also been used to treat patients with acute wounds [63] and following plastic skin surgery for scar reduction and orbital adhesion in centrofacial lifting [64].…”

“…[57] Diabetic foot ulcers-Complete healing of patients (12/12) exhibiting chronic resistance to previous therapy within 4–6 months.Papanas et al . [58] Heat burn-Complete healing after 4 months.Barritault et al . [59] Abrasive and electric burns-Case reports: healing and growth of granulation tissue.Roohi (unpublished data) Lower extremity ulcers associated with epidermolysis bullosa-Case report: healing of chronic, non-healing ulcers within 4 weeks.Malaq and Denis [62] Traumatic and plastic surgery-Case report: healing and growth of granulation tissue.Roohi (unpublished data) Plastic surgery: mammary reduction-Reduced inflammation, itching and scarring post-surgery.Zakine and Le Louarn [64] Plastic surgery: centrofacial lift-Reduced inflammation, swelling and bruising.Zakine and Le Louarn [64] Scalp lesions following surgery-Complete closure of the wound after 12 weeks.van Neck et al .…”

“…Similarly, in a study of diabetic patients presenting with non-healing foot ulcers, treatment with RGTA ® led to complete wound closure in 6 out of 10 patients, and a significant reduction in wound area in the remaining patients, after 10 weeks [56]. In a recent study involving type 2 diabetic patients with therapy resistant foot and lower extremity ulcers, local application of RGTA ® twice weekly led to complete healing in all patients (12/12) [58]. …”

ReGeneraTing Agents (RGTA®) are a new option to improve amputation outcomes in the recovery of severe hand injuries

“…RGTA ® s are heparan sulfate (HS) mimetics specifically designed to replace degraded heparan sulfates in damaged tissue, accelerating the speed and enhancing the quality of tissue repair 4. Their unique properties have been the subject of intensive preclinical and clinical studies 2, 3, 6, 7, 8, 9, 10, 11, 12. CACIPLIQ20 ® contains RGTA ® OTR4120, a biodegradable polymer of 1‐6 alpha polyglucose substituted with carboxymethyl and sulfated groups 4.…”

“…Here, we had the opportunity to use a new product named CACIPLIQ20 ® , which is based on matrix therapy and recommended to treat chronic wounds in diabetic patients 2, 3. Matrix therapy using RGTA ® (ReGeneraTing Agent) is an innovative, minimally invasive approach in the field of regenerative medicine that aims to promote tissue regeneration by reconstructing the cellular microenvironment following tissue injuries 4.…”