CACIPLIQ20® : Clinical trials
Published clinical trials
- Regenerating matrix-based therapy for chronic wound healing :
a prospective within-subject pilot study
SL Groah, MD, MSPH, SCI Research Center, National Rehabilitation Hospital, Washington, DC, USA;
A Libin, PhD, SCI Research Center, National Rehabilitation Hospital, Washington,DC, USA;
M Spungen, BS, SCI Research Center, National Rehabilitation Hospital, Washington, DC, USA;
K-L Nguyen, PT,Virginia Hospital Center, Arlington, VA, USA;
E Woods, BSN, SCI Research Center, National Rehabilitation Hospital, Washington, DC, USA;
M Nabili, MBE, Catholic University, Washington, DC,USA; J Ramella-Roman, PhD, Catholic University, Washington, DC, USA;
D Barritault, PhD, OTR3 SAS ,4 rue Française 75001,Paris, France
The aim of this study was to determine whether a skin-specific bioengineered regenerating agent (RGTA) heparan sulphate mimetic (CACIPLIQ20) improves chronic wound healing. The design of this article is a prospective within subject study. The setting was an urban hospital. Patients were 16 African-American individuals (mean age 42 years) with 22 wounds (mean duration 2·5 years) because of either pressure, diabetic, vascular or burnwounds. Two participants each were lost to follow-up or removed because of poor compliance, resulting in 18 wounds analysed. Sterile gauze was soaked with CACIPLIQ20 saline solution, placed on the wound for 5 min, then removed twice weekly for 4 weeks. Wounds were otherwise treated according to the standard of care. Twenty-two percent of wounds fully healed during the treatment period. Wounds showed a 15·2–18·1% decrease in wound size as measured by the vision engineering research group (VERG) digital wound measurement system and total PUSH scores, respectively, at 4 weeks (P = 0·014 and P = 0·003). At 8 weeks there was an 18–26% reduction in wound size (P = 0·04) in the remaining patients. Wound-related pain measured by the visual analogue pain scale and the wound pain scale declined 60%(P = 0·024) and 70% (P = 0·001), respectively. Patient and clinician satisfaction remained positive throughout the treatment period. It is concluded that treatment with CACIPLIQ20 significantly improved woundrelated pain and may facilitate wound healing. Patient and clinician satisfaction remained high throughout the trial.
- Matrix Protection Therapy in Vascular Disease: First Clinical Pilot Study of RGTA®
Pascal Desgranges?, Taïna Louissaint*, Eric Allaire?, Bertrand Godeau*, Ketty Kichenin+, Jean-Pierre Becquemin?, Denis Barritault**+>
? Department of Vascular Surgery, Henri Mondor Hospital , Paris-Est University, 51 avenue du Maréchal de Lattre de Tassigny, 94000 Creteil, France.
* Department of Endocrinology, Hospital Henri Mondor, Paris-Est University, 51 avenue du Maréchal de Lattre de Tassigny, 94000 Creteil, France
** CRRET, CNRS UMR 7149 Faculty of Science, Paris-Est University, avenue Gal de Gaulle, 94000 Créteil France; OTR3 SAS, 4 rue Française, 75001 Paris, France
+ OTR3 SAS, 4 rue Française, 75001 Paris, France
Background: Among patients who have non-healing leg ulcers due to critical limb ischaemia and who cannot undergo vascular surgery, 25% die and 50% require amputation within 1 year. No satisfactory solution is available for treating these patients. A device for topical application of engineered biodegradable nanopolymers mimicking heparan sulphates, known as RGTAs®, has produced promising results in preclinical models of chronic wounds .
Methods: We studied 14 chronic lower-extremity ulcers in 12 patients (median age, 71) with transcutaneous partial pressure of oxygen (TcPO2) <30 mmHg and ankle brachial pressure index (ABPI) <0.5. At baseline, mean ulcer duration was 7 months and mean ulcer surface area was 14.15 cm2. The RGTA device was used twice a week for one month and at all patients requests for another month and for some patient until ulcer healing or for 3 months. The percentage ulcer size decrease at 4 weeks versus baseline was the primary endpoint.
Findings: No adverse events were recorded. Ulcer size reduction at 4 weeks (primary outcome) was 35% ranging from 12-100%,(p<0.001) , increasing to 53% (p<0.001) at 8 weeks as 5 ulcers healed. RGTA was prolonged for 10 patients for a third months and 7 (50%) ulcers were completely healed. Follow up for 9 patients indicated that 8 were alive at 12 months, 6 at 2 years. Closed ulcers remained closed, none healed ulcers remained as such but one that eventually closed and no patient was amputated as a consequence of the none healed RGTA treated ulcer.
Interpretation: RGTA® therapy induced significant ulcer healing after 4 weeks in patients with severe ischemia for whom no other treatment options were available.
In going clinical trials
- Matrix protection therapy in diabetic foot ulcers: Pilot study evaluating the effect of CACIPLIQ20 on wound healing
Ines SLIM1, MD, Houda TAJOURI1, MD, Denis BARRITAULT2,3, PhD, Maha KACEM1, MD, Koussay ACH1, MD, Molka CHADLI-CHAIEB1, MD, Larbi CHAIEB1, MD
1. Endocrinology and Diabetology Department, Farhat Hached University hospital, Sousse, Tunisia 2. OTR3 4 rue Française Paris 75001 France 3. Laboratoire CRRET, CNRS UMR 7149 Faculté des Sciences , Université Paris Est Créteil, 94000 Créteil France
We aim to evaluate whether matrix protection therapy aids the management and the promotion of the healing of chronic wounds of lower extremity in diabetic patients. A total of ten diabetic patients with non-infected cutaneous chronic wounds were recruited among our patients undergoing best available moist environment treatment including control of their glycemia and foot discharge with a mean of 38 weeks with no sign of improvement (range 4-77wks). Each foot was its own control. CACIPLIQ20 was topically applied twice a week for 5 minutes and for a maximum of ten weeks.
Wound area measurements were repeated every week after starting treatment. Ulcer closure defined as 100% re-epithelialization. Average wound size assessed by planimetry was 7.5 cm2 ± 10 cm2 (wound volume 2.5 cm3 ± 4.00 cm3). All patients reacted and stagnant wounds started to improve rapidly with significant reduction in the mean wound area after one week (5.6 ± 8.8 cm2, p = 0.021) and four weeks (4 ± 8.6 cm2, p = 0.001) of treatment. At the 10 weeks final follow up, six patients healed (60% , primary end point) in an average time of 5.4 weeks and 3 remaining patients achieved a greater than 80% and one over 50% reduction in wound size (mean healed area after 10 weeks was 9.4 ± 7.6 cm²). After this 10 weeks periods none ulcer-healed patients were no more treated by CACIPLIQ20 but received standard care. After 6 months one ulcer healed completely, the other ulcers remained stagnant. Although further investigations on the potential effects of this product on chronic wound healing are required, to our knowledge, no other product would have accelerated by at least sevenfold the closure of none –healing diabetic foot ulcers under normal care. CACIPLIQ20 based Matrix therapy offers as a simple and safe solution to break the endless cycle of long standing and costly chronic wounds.
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